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Zinc-MNP Trial for Prevention of Diarrhea and Promotion of Linear Growth

NCT ID: NCT03406793

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2886 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-20

Study Completion Date

2020-01-12

Brief Summary

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This is a randomized, double-blind, community-based efficacy trial of different doses, forms, and frequencies of zinc supplementation for the prevention of diarrhea and promotion of linear growth among children 9-11 months of age in Dhaka, Bangladesh.

Detailed Description

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Zinc is essential to support growth in young children especially for tissues undergoing rapid cellular differentiation and turnover, such as those in the immune system and gastrointestinal tract. Therapeutic zinc supplementation has been initiated in low-income countries as part of diarrhea treatment programs to support these needs for young children but, the effects of preventive supplemental zinc as a tablet or as a multiple micronutrient powder (MNP) on child growth and diarrheal disease are mixed and pose programmatic uncertainties. Thus, a randomized, double-blind community-based efficacy trial of five different doses, forms, and frequencies of preventive zinc supplementation vs. a placebo was designed for a study in children aged 9-11 months in an urban community in Dhaka, Bangladesh. The primary outcomes of this 24-week study are incidence of diarrheal disease and linear growth. Study workers will conduct in-home morbidity checks twice weekly; anthropometry will be measured at baseline, 12 weeks and 24 weeks. Serum zinc and other related biomarkers will be measured in a subsample along with an estimate of the exchangeable zinc pool size using stable isotope techniques in a subgroup. Therapeutic zinc will be provided as part of diarrhea treatment, in accordance with Bangladesh's national policy. Therefore, the proposed study will determine the additional benefit of a preventive zinc supplementation intervention.

Conditions

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Diarrhea Stunting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1. Standard MNP

Group Type EXPERIMENTAL

Standard MNP

Intervention Type DIETARY_SUPPLEMENT

Standard MNP, 15 micronutrients (Vitamin A 400 µg, vitamin D 5 µg, vitamin E 5 mg, vitamin C 30 mg, thiamine 0.5 mg, riboflavin 0.5 mg, niacin 6 mg, pyridoxine 0.5 mg, vitamin B12 0.9 mg, folate 150 µg, iron 10 mg, zinc 4.1 mg, copper 0.56 mg, selenium 17.0 µg and iodine 90 µg). Daily supplementation for 24 weeks.

2. High zinc, low iron MNP

Group Type EXPERIMENTAL

High zinc, low iron MNP

Intervention Type DIETARY_SUPPLEMENT

Same as group 1, except with 10 mg zinc instead of 4.1 mg and 6 mg iron instead of 10 mg. Daily supplementation for 24 weeks.

3. High zinc, low/no iron

Group Type EXPERIMENTAL

High zinc, low/no iron on alternating days

Intervention Type DIETARY_SUPPLEMENT

Same as study group 1, except with 10 mg zinc instead of 4.1 mg, and 6 mg iron and no iron on alternating days instead of 10 mg. Daily supplementation for 24 weeks.

4. Dispersible zinc supplement

Group Type ACTIVE_COMPARATOR

Dispersible zinc supplement

Intervention Type DIETARY_SUPPLEMENT

10 mg zinc in a dispersible tablet. Daily supplementation for 24 weeks.

5. Intermittent zinc supplement

Group Type EXPERIMENTAL

Intermittent zinc supplement

Intervention Type DIETARY_SUPPLEMENT

10 mg zinc in a dispersible tablet. Daily supplementation for 14 days at baseline and 3 months, placebo tablet on all other days.

6. Placebo powder

Group Type PLACEBO_COMPARATOR

Placebo powder

Intervention Type DIETARY_SUPPLEMENT

Daily provision of a placebo powder for 24 weeks.

Interventions

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Standard MNP

Standard MNP, 15 micronutrients (Vitamin A 400 µg, vitamin D 5 µg, vitamin E 5 mg, vitamin C 30 mg, thiamine 0.5 mg, riboflavin 0.5 mg, niacin 6 mg, pyridoxine 0.5 mg, vitamin B12 0.9 mg, folate 150 µg, iron 10 mg, zinc 4.1 mg, copper 0.56 mg, selenium 17.0 µg and iodine 90 µg). Daily supplementation for 24 weeks.

Intervention Type DIETARY_SUPPLEMENT

High zinc, low iron MNP

Same as group 1, except with 10 mg zinc instead of 4.1 mg and 6 mg iron instead of 10 mg. Daily supplementation for 24 weeks.

Intervention Type DIETARY_SUPPLEMENT

High zinc, low/no iron on alternating days

Same as study group 1, except with 10 mg zinc instead of 4.1 mg, and 6 mg iron and no iron on alternating days instead of 10 mg. Daily supplementation for 24 weeks.

Intervention Type DIETARY_SUPPLEMENT

Dispersible zinc supplement

10 mg zinc in a dispersible tablet. Daily supplementation for 24 weeks.

Intervention Type DIETARY_SUPPLEMENT

Intermittent zinc supplement

10 mg zinc in a dispersible tablet. Daily supplementation for 14 days at baseline and 3 months, placebo tablet on all other days.

Intervention Type DIETARY_SUPPLEMENT

Placebo powder

Daily provision of a placebo powder for 24 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 9-11 months of age
* Weight-for-length Z score \>= -3 according to the 2006 World Health Organization Growth Standards
* Hemoglobin concentration \> = 7.0 g/dL

Exclusion Criteria

* Presence of severe acute malnutrition, defined as a WLZ \<-3 and/or the presence of bipedal edema and/or mid-upper arm circumference \<115 mm;
* Presence of severe anemia, defined as a hemoglobin concentration \< 7.0 g/dL
* Congenital anomalies (e.g. cardiac defects, cleft lip or palate) or any other conditions that interfere with feeding;
* Chromosomal anomalies and other organic problems (e.g. jaundice, tuberculosis)
* Currently consuming MNPs with no intention of stopping
Minimum Eligible Age

9 Months

Maximum Eligible Age

11 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Black, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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Icddr,B

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

References

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Islam MM, Black RE, Krebs NF, Westcott J, Long J, Islam KM, Peerson JM, Sthity RA, Khandaker AM, Hasan M, El Arifeen S, Ahmed T, King JC, McDonald CM. Different Doses, Forms, and Frequencies of Zinc Supplementation for the Prevention of Diarrhea and Promotion of Linear Growth among Young Bangladeshi Children: A Six-Arm, Randomized, Community-Based Efficacy Trial. J Nutr. 2022 May 5;152(5):1306-1315. doi: 10.1093/jn/nxab439.

Reference Type DERIVED
PMID: 35015856 (View on PubMed)

Other Identifiers

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1.05

Identifier Type: -

Identifier Source: org_study_id