Can I Take an Iron Supplement and Zinc Supplement Together?

Abstract

Background/Objectives:

Many children accept diets scarce in both iron and zinc, only in that location has been some testify of negative interactions when they are supplemented together. The optimal delivery approach would maximize clinical benefits of both nutrients. We studied the effectiveness of unlike iron and zinc supplement delivery approaches to improve diarrhea and anemia in a rural People's republic of bangladesh population.

Written report Design:

Randomized, double bullheaded, placebo-controlled factorial community trial.

Results:

Iron supplementation lonely increased diarrhea, but adding zinc, separately or together, attenuated these harmful furnishings. Combined zinc and iron was every bit constructive as atomic number 26 alone for iron outcomes. All supplements were vomited <i% of the time, but combined fe and zinc were vomited significantly more than whatsoever of the other supplements. Children receiving zinc and iron (together or separately) had fewer hospitalizations. Separating delivery of iron and zinc may have some additional benefit in stunted children.

Conclusions:

Split up and combined assistants of iron and zinc are equally constructive for reducing diarrhea, hospitalizations and improving atomic number 26 outcomes. There may be some benefit in separate administration in stunted children.

Introduction

Zinc and atomic number 26 deficiencies frequently co-exist in developing nations. These minerals are derived from similar food sources and assimilation tin can be inhibited past phytate-containing cereals (Gibson, 1994). Concomitant malnutrition, reduced immune status, and exposure to bacterial pathogens, further increase risks of diarrhea and contribute to micronutrient deficiencies (Castillo-Duran and Vial, 1988).

Childhood iron deficiency has long been recognized as one of the most prevalent micronutrient deficiencies (UNICEF, 2001). Since January 1995, the UNICEF/WHO Joint Committee on Health Policy endorsed a strategy for reducing iron deficiency anemia in children. In improver to decreasing anemia, fe supplementation may too improve psychomotor activity (Berth and Aukett, 1997; de Andraca et al., 1997). Zinc is increasingly used to reduce babyhood morbidity and mortality from diarrhea and pneumonia, and potentially meliorate growth (Lind et al., 2004; Bhutta et al., 1999; Sazawal et al., 2001; Brownish et al., 2002).

Concerns almost the condom of fe on growth and diarrhea (Gera and Sachdev, 2002; Iannotti et al., 2006) accept chosen into question the safety of universal fe supplementation. Show of antagonistic interactions between iron and zinc farther complicate the movie. Fischer Walker et al. (2005) reviewed studies on the interaction of atomic number 26 and zinc and found inconsistent evidence that co-supplementation decreased the benefit of zinc on diarrhea. She also found that co-supplementation may decrease the hematologic response compared with iron alone. We conducted a study of the interaction of atomic number 26 and zinc on clinical outcomes when these minerals are supplemented separately versus together, which has non been done earlier.

Methods

Written report participants

This randomized, double blind factorial customs trial of children half dozen–18 months was conducted in Mirzapur, Bangladesh, a rural sub-district (thana) located 60 km due north of the capitol Dhaka. Children were recruited from 2 unions 11 and 12 km walking distance northwest of Kumudini Infirmary, a free private hospital serving all of Mirzapur, with additional recruitment from a convenience sample of villages in ii unions 2.5 km east and xx km northeast of Kumudini Hospital.

Nosotros enrolled all 6–18-calendar month-onetime permanent residents of the selected villages. If one family had two eligible children, one was randomly selected for enrollment. Children with severe malnutrition (weight for peak z-score <−three s.d.), severe anemia (hemoglobin <70 yard/l), chronic illnesses that would impair feeding power, planned move during the report period, or active fever >38.5 °C were excluded from the written report and evaluated at Kumudini Hospital, as appropriate.

Mirzapur has birth and infant and child mortality rates of 27/1000 population, lxxx/1000 live births and 110/g alive births, respectively, like to the national averages. Children are breastfed until 1–two years of age and introduced to a plant-based diet around vi months. The surface area floods regularly during the monsoon season and agriculture is the primary occupation.

Intervention

Children were randomized to receive 6 months of ane of five different intervention regimens containing various combinations of iron/folic acrid, zinc, and placebo.

1. one)

   daily placebo (placebo)

2. 2)

   daily alternate zinc and placebo (zinc lonely)

3. 3)

   daily alternating iron/folic acid/zinc and placebo (combined iron and zinc)

4. 4)

   daily alternating iron/folic acid and placebo (iron alone)

5. 5)

   daily alternating zinc and fe/folic acid (iron and zinc separately)

Zinc was supplied in 10 mg scored, dissolvable tablets in blister packs of 10 (average dose of 5 mg per twenty-four hours for the groups receiving zinc). Atomic number 26 and folic acid was supplied in cicatrice packs of x scored, dissolvable tablets with 12.5 mg fe (average dose of vi.25 mg per day for groups receiving atomic number 26) and 50 IU folic acid per tablet. Placebo was identical in color, shape, taste. Tablets were manufactured by Nutriset Southward.A.S. (Malaunay, France). Trained village wellness workers (VHWs) demonstrated, instructed, and supervised the mother on proper administration of tablets. Tablets were reconstituted in 5 ml of water and given to the children ⩾12 months daily on an empty stomach. Reconstituted half tablets were given to children <12 months (boilerplate dose of 2.5 mg zinc per day and average three.125 mg atomic number 26 per day). For missed doses, the mother gave the child the side by side morning dose, and a 2d dose in the evening.

VHWs were required to have completed at least viii years school and preferably be a permanent resident of the assigned village cluster. VHW training included a preliminary vii days on recruitment protocols, data collection methods, and supplement pedagogy, and a vii-solar day refresher later on three months. 4 trained supervisors, with at least 12 years of school and earlier research feel, each oversaw half-dozen VHWs. They personally accompanied and checked each VHWs assessment at to the lowest degree once weekly. They double checked each follow-upward form for missing data and used standardized forms to check for accuracy in tablet counts and adherence reporting.

Enrollment and supplementation began 8 May 2007, with the last follow-up and supplementation on 29 February 2008. Efforts were made to discover and collect final claret samples for all children, fifty-fifty after the follow-upwards time menses had ended.

Study outcomes

Diarrhea incidence was the main consequence of this study. A diarrhea episode was divers as three or more loose, liquid, or watery stools for ii consecutive days, separated in time from an earlier or subsequent episode past at least ii consecutive diarrhea-complimentary days. Secondary outcomes included other clinical outcomes of diarrhea prevalence, incidence of dysentery, diarrhea with aridity, and hospitalization, and biochemical outcomes of hemoglobin, serum zinc concentration, and serum transferrin receptor.

VHWs visited each child weekly to assess the child'south health status and the previous week's diarrhea and supplement adherence or intolerance. If the kid was absent-minded, the VHW revisited daily for 3 subsequent days. The VHW would render on the next assigned visit and, if absent, continue the aforementioned procedure until 6 months from initial enrollment.

At the completion of follow-up, children initially randomized to having blood drawn who were followed for at least 22 weeks had blood drawn for laboratory assessment by a trained nurse at Kumudini Infirmary. A trained laboratory technician analyzed capillary blood from finger prick for hemoglobin value past Hemocue machine and spun, centrifuged and stored venous bloods at −20 °C before transferring them to the ICDDR,B laboratory every ii weeks on dry ice. Zinc was measured using atomic absorption spectrometry (model AA-6501S, manufacturer Shimadzu Co, Japan, Zinc stock standard 1000 mg/l, BDH, VWR, Great britain, Quality command from UTAK lab Inc). Serum transferrin receptor was measured by particle-enhanced immunoturbidimetric assay (Hitachi-902, manufacturer Roche, scale kits from Roche, Mannheim, Germany). Each lot of 35 samples was calibrated using commercial and standard car kits. For additional quality control, samples were pooled in groups of 10 and any lot with a value greater or less than two s.d. was re-analyzed.

Information were entered using the Visual Basic plan and stored in an SQL server. Data were checked for consistency for beyond study ID, duplication, and missing data confronting a listing file. Data entry was checked for data exterior of normal ranges.

Sample size

Sample size calculation was based on multiple-arm comparisons with predictable ten% withdrawals due to out-migration or refusal, and powered for α=0.05 and 80% power. Full sample size was sufficient to reduce a baseline rate of 3.5 episodes per child-year (Baqui et al., 2003) past twenty%. Sampling for laboratory outcomes was based on multiple-arm comparisons to discover a 15% increase in serum zinc, which would also observe a 4% increase in hemoglobin.

Randomization

Block randomization in groups of ten were computer generated. Sealed envelopes concealing supplement group allocation were opened sequentially only after complete conclusion of enrollment eligibility.

Blinding or masking

The manufacturer provided supplements with blinded designation. The principal investigator lonely stored the lawmaking in a remote location from the written report site. Analyses were performed in a blinded fashion. The code was not revealed until the time of manuscript preparation.

Statistical methods

Weight and height Z-scores were calculated with EPIinfo. Diarrhea outcomes and laboratory analyses were calculated according to a pre-established analysis plan with STATA 9.0 statistical software (Stata Corp: Stata Statistical Software: Release 9.0, Stata Corporation, College Station, TX, 2002). Baseline proportions and means were compared using the χ² test. Primary and secondary outcomes were a priori hypotheses and thus we did not adjust for multiple comparisons. Incidence and prevalence of affliction and frequency of vomiting or adverse events were compared with Poisson regression. Laboratory and anthropometric outcomes were compared using analysis of variance, and adjusted for baseline value and historic period. Two-sided significance tests were used throughout. Every bit a hypothesis-generating exercise, additional analyses were run to evaluate effects of age, sexual practice, inflammation, stunted, and underweight status on various outcomes. These factors were starting time evaluated for primary effect on outcomes, and so for issue modification of supplements on outcomes.

Results

Participants

Age-eligible children were recruited from 8 May 2007 to 31 August 2007. Children were followed up weekly for 26 weeks.

Figure i shows the flow of participants from study recruitment to follow-upwards and assay. Of 1473 children, potentially eligible children identified from census data, 1150 children were screened to meet target enrollment of thou children. Of the 1150 children screened, 143 families had refused while 7 children were not eligible due to severe anemia.

Effigy one

Enrollment, randomization, and follow-upwards.

Full size image

Of thousand children initially enrolled, 96.5% of children were followed for at least xc% of the full eligible time, with a total of 493.iii child-years in the final analyses. Of the 500 children originally randomized to have blood fatigued for laboratory analysis, 444 had follow-up bloods drawn (Figure 1).

Protocol deviations

Ix participants received the incorrect samples from enrollment. They were continued and analyzed by the supplement that they actually received. In add-on, ii participants received the incorrect combination of supplements for longer than one week. One child received one group of supplements for 1 calendar month, and another received ii different supplement combinations for 1 week each. Each of these participants were returned to their original supplement combination as presently as possible and analyzed in an intention-to-treat fashion. Results were not inverse when these children were dropped from the analyses.

One child was enrolled in the iron alone group despite weight for acme z-score <−three. This kid was connected in the study and experienced no complications. One kid was enrolled despite a history of cerebral palsy and swallowing dysfunction. This child received iron alone and was afterwards excluded from the study.

Because of the demand to follow-upwards children until they were able to be seen in the hospital for end-of-study measurements and blood draws, 254 children were followed upward for longer than 26 weeks.

Baseline demographics

Table i describes the baseline demographic and clinical characteristics of children enrolled in each supplement group. Overall, 51.6% of children enrolled were males, with fewer in the placebo and combined iron and zinc groups. The groups otherwise were not significantly different for other pre-specified baseline characteristics. On boilerplate, enrolled children were xi months old, with hateful weight for age z-score −i.5 and baseline hemoglobin of 93 g/fifty.

Tabular array ane Baseline characteristics of all children at enrollment, past intervention group

Full size table

The sub-sample of children randomized to accept blood drawn for laboratory analysis showed similar characteristics to the overall group and baseline characteristics did not differ past supplement type (data not shown). Baseline serum zinc level for this sub-sample was 9.9 μmol/l and baseline serum transferrin receptor was 6.9 mg/fifty.

Summary of results

The overall diarrhea incidence was 2.3 episodes per child per year for children receiving placebo (Table 2). Zinc lonely did not provide significant benefit on overall diarrhea incidence, prevalence, or duration compared with placebo alone. However, atomic number 26 lonely increased diarrhea prevalence. Iron solitary did not bear on elapsing, suggesting that the increased prevalence was primarily due to increased number of episodes (260 vs 235), although the increment in diarrhea incidence over placebo was not statistically significant. Any increased episodes in the iron alone grouping could be attributed to both an increased number of children with any episode (125 vs 119) too as increased repeat episodes. Adding zinc to atomic number 26, in combination or separately, reduced diarrhea incidence and prevalence compared with iron lone. Whatever combination of zinc (solitary, combined with fe, or separately with iron) significantly decreased the incidence of diarrhea with dehydration compared with iron solitary. Combined atomic number 26 and zinc reduced the incidence of bloody diarrhea compared with all other groups.

Table 2 Effect of supplements on diarrhea outcomes

Total size table

Final serum zinc concentration was significantly increased with supplementation of zinc lone or administered separately with iron (Table 3). Whatsoever combination of iron (alone, in combination, or separately with zinc) decreased serum transferrin receptor. Only atomic number 26 alone or in combination with zinc significantly increased hemoglobin, nevertheless. Supplementation with combined iron and zinc resulted in the most children with increased C-reactive protein. C-reactive protein and inflammation condition were not associated with zinc status nor did they modify the upshot of supplements on zinc status (information not shown).

Table 3 Result of supplements on iron and zinc lab indices

Full size table

Sub-analyses

Sub-analyses for the chief outcomes are presented in Table 4. Stunted (summit for age Z-score <−2s.d.) and underweight (weight for age Z-score <−2s.d.) children receiving placebo had similar rates of diarrhea compared with non-stunted or non-underweight children. However, zinc was more effective in stunted or underweight populations at reducing diarrhea given alone or with atomic number 26. Stunted children had greater benefit from divide (vs combined) atomic number 26 and zinc supplementation. Giving iron solitary to underweight children had less detrimental effects on diarrhea prevalence. Infants (<12 months) had consistently more diarrhea than older children (⩾12 months), regardless of what supplement type they received. Sex did not seem to affect baseline risk for diarrhea, although iron alone increased days of diarrhea in girls more boys.

Table four Sub-analysis of diarrhea incidence and prevalence

Total size table

Although in that location was some testify of different laboratory or anthropometric outcomes due to differences in baseline run a risk (that is iron indices better in younger infants, growth outcomes better in malnourished children), there were few significant differing effects across supplement groups (information non shown).

Adherence and tolerance

Overall supplement adherence during follow-upward was 81.nine%. Adherence did not differ significantly by supplement type. Out-migration accounted for xi.2% of non-adherence. Families took supplements 92.2% of the time when they were present at home. Supplements were mostly well tolerated with <one% supplements vomited in all groups, but significantly more vomiting with supplements of combined iron and zinc (0.viii%) (information not shown).

Adverse events

There were eighty hospitalizations in full (Tabular array five). Ii deaths occurred, both in placebo grouping. Bronchiolitis was the most common reason for hospitalization. Zinc and iron (administered together or dissever) reduced all-cause hospitalization. Zinc given solitary reduced infection-related hospitalizations. Any combination of zinc (alone, in combination, or separately with iron) reduced hospitalizations for bronchiolitis.

Tabular array 5 Hospitalizations, by supplement type

Full size table

Discussion

Policy makers accept struggled with recommending the best iron and zinc regimen in areas with a loftier prevalence of concomitant iron and zinc deficiency. Earlier recommendations considered that, in areas with endemic anemia, the benefits of universal iron supplementation outweighed risks. All the same, contempo research has shed new light on the condom of universal fe supplementation. On the basis of the results of a large randomized-controlled trial in Zanzibar (Sazawal et al., 2006), the World Health System now recommends targeted, rather than universal, atomic number 26 supplementation in malaria-endemic areas (de Benoist et al., 2006). Nevertheless, fe with or without zinc was not found to increment mortality or hospitalizations in Nepal (Tielsch et al., 2006) leaving open the question of whether to recommend routine iron supplementation in non-malaria endemic areas (English language and Snowfall, 2006)

Even in the absence of increased morbidity or mortality, universal iron supplementation is not without risks. Iron alone may adversely touch weight gain and diarrhea (Gera and Sachdev, 2002; Iannotti et al., 2006). In both trials in Zanzibar and Nepal, concurrent iron administration with zinc reduced the beneficial effects of zinc lonely on reduced hospitalizations and deaths in children >12 months (Black R, personal communication).

This study found that iron alone increased diarrhea, but that these harmful furnishings were modified by adding zinc, either separately or combined. This study found an overall lower than expected incidence of diarrhea than expected, resulting in decreased statistical power. This may have been due to improved nutrition and health over fourth dimension. This improved nutrition and reduced ability may take contributed to the lack of effectiveness of zinc lonely, as has been found in earlier studies (Bhutta et al., 1999; Baqui et al., 2003), and possibly contributed to the lack of difference in separating atomic number 26 and zinc compared with combined supplementation. Hypothesis-generating sub-analyses that found greater zinc effectiveness in stunted populations support this possibility contributed. Sub-analyses also found that separating iron and zinc improved diarrhea greater in stunted populations than when combined, suggesting that the interaction effect of iron on zinc may be unlike in stunted children and that the effectiveness of various delivery methods may be different in some specific populations.

Consistent with earlier studies, zinc given alone, with or without iron, increased zinc levels, but concomitant administration of fe negated this result (Lind et al., 2003; Berger et al., 2006; Wieringa et al., 2007). As expected, iron increased iron outcomes of hemoglobin and serum transferrin. Co-supplementation with iron and zinc was as effective every bit iron solitary for increasing hemoglobin. Considering potential measurement errors with hemoglobin measurement past Hemocue, it is important to consider trends across all iron outcomes, including serum transferrin. The tendency suggested that any iron supplementation (lonely, combined, or separately with zinc) improved iron outcomes.

We found that although children vomited combined iron and zinc tablets significantly more often than whatsoever other supplement blazon, this did not result in any decreased overall adherence. However, children receiving both zinc and iron (combined or separately with iron) had fewer hospitalizations. This effect was primarily related to the zinc upshot in reducing bronchiolitis and infection-related hospitalizations. Although non completely understood, this is consequent with findings of reduced morbidity and acute lower respiratory tract infection with simultaneous fe and zinc administration (Baqui et al., 2003).

The findings from this study regarding the effects and interaction of atomic number 26 and zinc are applicable to non-malaria endemic populations with similar plant-based, nutrient-poor diets. Iron supplementation solitary increased diarrhea outcomes, but adding zinc attenuated these harmful effects. Calculation zinc to iron was as effective as iron alone for most atomic number 26 outcomes. Iron and zinc co-supplementation seems to optimize outcomes of diarrhea, atomic number 26, and hospitalizations for this population. Separating delivery of atomic number 26 and zinc may have some additional benefit in stunted children.

Conflict of interest

The authors declare no conflict of involvement.

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Acknowledgements

This report was funded by the Us Agency for International Development through the Global Research Action honour #HRN-A-00-96-90006-00 to the Johns Hopkins Bloomberg School of Public Wellness. Nosotros thank Saifuddin Ahmed (Johns Hopkins Bloomberg School of Public Health) and Parivash Nourjah (Johns Hopkins Medical Institutions, Agency for Healthcare Research and Quality) for their statistical assistance, Hervé-Pierre Le Goascoz (Nutriset) and Neal Brandes (USAID) for their assistance and back up through this project, and most of all the entire ICDDR,B squad, the Kumudini infirmary staff, and the Mirzapur customs.

Author information

Affiliations

1. Johns Hopkins Medical Institutions, Agency for Healthcare Research and Quality, Rockville, Dr., USA

   S Chang

2. International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), Dhaka, Bangladesh

   Due south El Arifeen, S Bari, Chiliad A Wahed, K One thousand Rahman, G T Rahman, A B A Mahmud, N Begum & K Zaman

3. Johns Hopkins Bloomberg School of Public Health, Baltimore, Physician, The states

   A H Baqui & R E Blackness

Corresponding author

Correspondence to South Chang.

Boosted data

Contributors: SC, AB, RB, SA, MW, KZ contributed to study pattern. SA, SB, MW, KMR, TR, AM, NB contributed to collection of information. SC, RB contributed to analysis of data. SC prepared the offset draft of the manuscript. All authors provided significant advice, contributed to, and approved the final manuscript.This study was registered in clinicaltrials.gov (identifier number NCT00470158), and approved by the Johns Hopkins Bloomberg School of Public Health Institutional Review Board (H.22.05.03.xi.C2) and the International Heart for Diarrhoeal Disease Enquiry, Bangladesh Ethical Review Committee (2005-040).

Disclaimer

The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions exercise not necessarily represent the views of AHRQ or USAID. Therefore, no argument in this report should exist construed as an official position of these entities, the US Department of Health and Human Services, or the U.s. Agency for International Development.

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Chang, S., El Arifeen, S., Bari, S. et al. Supplementing iron and zinc: double blind, randomized evaluation of separate or combined delivery. Eur J Clin Nutr 64, 153–160 (2010). https://doi.org/10.1038/ejcn.2009.127

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• Received: 28 February 2009

• Revised: 26 July 2009

• Accepted: 27 July 2009

• Published: xi November 2009

• Issue Date: February 2010

• DOI : https://doi.org/ten.1038/ejcn.2009.127

Keywords

• iron
• zinc
• supplement
• delivery
• interaction
• diarrhea

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