NCT03406793

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

Randomized, Double-blind, Community-based Efficacy Trial of Various Doses of Zinc in Micronutrient Powders or Tablets in Young, Bangladeshi Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,886 (actual)
• Sponsor: UCSF Benioff Children's Hospital Oakland · Academic / Other
• Sex: All
• Age: 9 Months – 11 Months
• Healthy volunteers: Accepted

Summary

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

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

• Diarrhea
• Stunting

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
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.
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.
DIETARY_SUPPLEMENT	Dispersible zinc supplement	10 mg zinc in a dispersible tablet. Daily supplementation for 24 weeks.
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.
DIETARY_SUPPLEMENT	Placebo powder	Daily provision of a placebo powder for 24 weeks.

Timeline

• Start date: 2018-02-20
• Primary completion: 2020-01-12
• Completion: 2020-01-12
• First posted: 2018-01-23
• Last updated: 2020-11-03

Locations

1 site across 1 country: Bangladesh