A Phase 4 interventional study of iron and zinc combined and iron and zinc on separate days in Anemia, Diarrhea and Iron, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Bangladesh. Open to participants aged 6 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-20.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 4, Interventional, and Prevention
With the long-term public health goal of developing an effective micronutrient supplementation program to improve child health by improving iron and zinc status and decreasing morbidity due to diarrhea in areas with high rates of childhood malnutrition, we seek to determine the most efficacious method of decreasing childhood morbidity and mortality due to diarrhea in toddlers by re-examining the issue of iron and zinc interaction and determining if this interaction can be minimized by separate administration of iron and zinc supplementation.
Iron supplementation is used in reducing anemia and improving hemoglobin status. Zinc supplementation is emerging as possibly an efficacious preventive measure in decreasing incidence of severe diarrhea. Previous studies have suggested interactions of zinc and iron when given together, reducing the effects of supplementation with both minerals. One study in Peru has shown a decrease in interaction effect with separate supplementation of iron and zinc in time when compared to iron administration alone or placebo; however, an evaluation of clinical outcomes and zinc or iron status when iron and zinc are administered separately compared to supplementation of zinc and iron together or each alone has not previously been done. This trial will assess the effect of iron and zinc supplementation given on alternate days compared with giving them together in a combined supplement.
We propose a randomized, double blind, placebo-controlled community trial of children 6-23 months in Mirzapur, Bangladesh. We will recruit and enroll 1000 children 6-23 months old who are permanent residents of the selected villages. Each child will be randomly assigned to 1) daily alternating zinc and placebo 2) daily alternating iron/folic acid and placebo 3) daily alternating zinc/iron/folic acid and placebo 4) daily alternating zinc and iron/folic acid 5) daily placebo. Primary outcomes will include incidence of severe diarrhea, evaluated weekly for 6 months, hemoglobin, prevalence of anemia, and serum zinc.
Analysis of the data will be done to compare the effect of separate iron and zinc supplementation as compared to combined iron and zinc supplementation as well as compared to iron, zinc, or placebo single supplementation. We will evaluate the difference in incidence rate of severe diarrhea, serum hemoglobin, percent anemia, and serum zinc. Since this will be a randomized, double-blind, placebo controlled trial, differences in effect will be most likely explained by the timing of supplement doses. If there is an improvement in clinical and biochemical outcomes, this would be consistent with a decreased interaction of absorption. If no difference is found, there may be another mechanism for the seeming interaction of iron and zinc besides that of mutually inhibitory absorption in the intestine.
852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.
This study's enrollment of 1,000 is above the median of 136 across 713 interventional studies indexed under Diarrhea.
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Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
Iron and zinc together
Dietary Supplement: iron and zinc combined
Iron and zinc on separate days
Dietary Supplement: iron and zinc on separate days
Iron
Dietary Supplement: iron
Zinc
Dietary Supplement: Zinc
Dietary Supplement: placebo
Children \>= 12 months received an average of 5mg zinc/day, 6.25 Iron/day, and 25IU folic acid/day. children\<12 received half that dose. This dose was alternated daily with placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
Also known as: Tablets were manufactured by Nutriset, S.A.S. (Malaunay, France).
Children \>= 12 months received an average of 5mg zinc/day, alternating daily with 6.25 Iron/day, and 25IU folic acid/day. Children\<12 received half that dose. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
Also known as: Tablets were manufactured by Nutriset, S.A.S. (Malaunay, France).
Children \>= 12 months received an average 6.25 Iron/day, and 25IU folic acid/day. Children\<12 received half that dose. This dose was alternated daily with placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
Children \>= 12 months received an average of 5mg zinc/day. Children\<12 received half that dose. This dose was alternated daily with placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
Children received daily placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
Incidence of Diarrhea
A diarrhea episode was defined as three or more loose, liquid, or watery stools for 2 consecutive days, separated in time from an earlier or subsequent episode by at least 2 consecutive diarrhea-free days.
Time frame: 6 months
Change in Hemoglobin
Time frame: 6 months
Change in Zinc Status
Time frame: 6 months
Percent Anemic
Time frame: 6 months
All 6-18 month old permanent residents of selected villages near Kumudini Hospital were enrolled from May 8, 2007-August 31, 2007.
| Milestone | Combined Iron and Zinc | Separate Iron and Zinc | Iron Alone | Zinc Alone | Placebo |
|---|---|---|---|---|---|
| Started | 201 | 199 | 201 | 198 | 201 |
| Completed | 193 | 191 | 193 | 193 | 195 |
| Not completed | 8 | 8 | 8 | 5 | 6 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 2 |
| Withdrew: Lost to follow-up | 7 | 8 | 8 | 5 | 4 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 | 0 |
A diarrhea episode was defined as three or more loose, liquid, or watery stools for 2 consecutive days, separated in time from an earlier or subsequent episode by at least 2 consecutive diarrhea-free days.
| episodes | Combined Iron and Zinc | Separate Iron and Zinc | Iron Alone | Zinc Alone | Placebo |
|---|---|---|---|---|---|
| Incidence of Diarrhea | 201 | 204 | 260 | 224 | 235 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Combined Iron and Zinc | — | 11/201 (5.5%) | 2/201 (1%) |
| Separate Iron and Zinc | — | 8/199 (4%) | 2/199 (1%) |
| Iron Alone | — | 17/201 (8.5%) | 0/201 (0%) |
| Zinc Alone | — | 10/198 (5.1%) | 4/198 (2%) |
| Placebo | — | 22/201 (10.9%) | 4/201 (2%) |
| Event | Combined Iron and Zinc | Separate Iron and Zinc | Iron Alone | Zinc Alone | Placebo |
|---|---|---|---|---|---|
| infectious hospitalizationsInfections and infestations | 11/201 | 8/199 | 17/201 | 10/198 | 22/201 |
| Event | Combined Iron and Zinc | Separate Iron and Zinc | Iron Alone | Zinc Alone | Placebo |
|---|---|---|---|---|---|
| noninfectious hospitalizationsPregnancy, puerperium and perinatal conditions | 2/201 | 2/199 | 0/201 | 4/198 | 4/201 |
| Age, Categorical(Participants) | Combined Iron and Zinc | Separate Iron and Zinc | Iron Alone | Zinc Alone | Placebo | Total |
|---|---|---|---|---|---|---|
| <=18 years | 201 | 199 | 201 | 198 | 201 | 1000 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Combined Iron and Zinc | Separate Iron and Zinc | Iron Alone | Zinc Alone | Placebo | Total |
|---|---|---|---|---|---|---|
| Mean | 0.93 ± 0.31 | 0.925 ± 0.32 | 0.9 ± 0.33 | 0.925 ± 0.33 | 0.9 ± 0.32 | 0.92 ± 0.32 |
| Sex: Female, Male(Participants) | Combined Iron and Zinc | Separate Iron and Zinc | Iron Alone | Zinc Alone | Placebo | Total |
|---|---|---|---|---|---|---|
| Female | 87 | 107 | 93 | 109 | 88 | 484 |
| Male | 114 | 92 | 108 | 89 | 113 | 516 |
| Region of Enrollment(participants) | Combined Iron and Zinc | Separate Iron and Zinc | Iron Alone | Zinc Alone | Placebo | Total |
|---|---|---|---|---|---|---|
| Bangladesh | 201 | 199 | 201 | 198 | 201 | 1000 |
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Johns Hopkins Bloomberg School of Public Health