Zinc-MNP Trial for Prevention of Diarrhea and Promotion of Linear Growth
Condition: Diarrhea; Stunting
MeSH terms: Diarrhea; Growth Disorders
Study type: Interventional

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.
    

Intervention name(s): Standard MNP; High zinc, low iron MNP; High zinc, low/no iron on alternating days; Dispersible zinc supplement; Intermittent zinc supplement; Placebo powder
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.; 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.; 10 mg zinc in a dispersible tablet. Daily supplementation for 24 weeks.; 10 mg zinc in a dispersible tablet. Daily supplementation for 14 days at baseline and 3 months, placebo tablet on all other days.; Daily provision of a placebo powder for 24 weeks.
Intervention MeSH terms: Iron; Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Zinc; Multiple micronutrient powders; Diarrhea; Stunting