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

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.

Conditions

• Diarrhea
• Stunting

Interventions

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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• UCSF Benioff Children's Hospital Oakland

  lead OTHER

Principal Investigators

• Robert Black, MD, MPH · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

9 Months

Max Age

11 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-02-20

Primary Completion

2020-01-12

Completion

2020-01-12

Countries

• Bangladesh

Study Locations