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

NCT03406793 | Completed DMC

• 1 other identifier: 1.05
• Study Type: interventional
• Target: 2,886
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Zinc; Multiple micronutrient powders; Diarrhea; Stunting

Outcome Measures

Primary Outcomes (2)

• Incidence of diarrhea

  Incidence of diarrhea is defined as the number of diarrheal episodes per person-weeks of follow-up

  Incidence over the 24-week follow-up period

• Change in length-for-age Z score

  Change in length-for-age Z score from enrollment to the end of the 24-week follow-up period

  Measured at enrollment and the end of the 24-week follow-up period

Secondary Outcomes (17)

• Change in stunting prevalence

  Measured at enrollment and the end of the 24-week follow-up period

• Change in wasting prevalence

  Measured at enrollment and at the end of the 24-week follow-up period

• Incidence of dysentery

  Measured twice weekly for 24 weeks

• Incidence of diarrhea with dehydration

  Measured twice weekly for 24 weeks

• Incidence of hospitalizations

  Assessed twice weekly for 24 weeks

Study Arms (6)

1. Standard MNP

EXPERIMENTAL

Dietary Supplement: Standard MNP

2. High zinc, low iron MNP

EXPERIMENTAL

Dietary Supplement: High zinc, low iron MNP

3. High zinc, low/no iron

EXPERIMENTAL

Dietary Supplement: High zinc, low/no iron on alternating days

4. Dispersible zinc supplement

ACTIVE COMPARATOR

Dietary Supplement: Dispersible zinc supplement

5. Intermittent zinc supplement

EXPERIMENTAL

Dietary Supplement: Intermittent zinc supplement

6. Placebo powder

PLACEBO COMPARATOR

Dietary Supplement: Placebo powder

Interventions

Standard MNP 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.

1. Standard MNP

High zinc, low iron MNP 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.

2. High zinc, low iron MNP

High zinc, low/no iron on alternating days 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.

3. High zinc, low/no iron

Dispersible zinc supplement DIETARY_SUPPLEMENT

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

4. Dispersible zinc supplement

Intermittent zinc supplement 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.

5. Intermittent zinc supplement

Placebo powder DIETARY_SUPPLEMENT

Daily provision of a placebo powder for 24 weeks.

6. Placebo powder

Eligibility Criteria

• Age: 9 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

Icddr,B

Dhaka, Bangladesh

Location

Related Publications (1)

• 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.

  PMID: 35015856 DERIVED

MeSH Terms

Conditions

Diarrhea; Growth Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Robert Black, MD, MPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 23, 2018
• Study Start: February 20, 2018
• Primary Completion: January 12, 2020
• Study Completion: January 12, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)