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

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ClinicalTrials.gov Identifier: NCT03406793
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
Johns Hopkins Bloomberg School of Public Health
University of Colorado, Denver
Information provided by (Responsible Party):
Christine McDonald, Children's Hospital & Research Center Oakland

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.

Condition or disease Intervention/treatment Phase
Diarrhea Stunting Dietary Supplement: Standard MNP Dietary Supplement: High zinc, low iron MNP Dietary Supplement: High zinc, low/no iron on alternating days Dietary Supplement: Dispersible zinc supplement Dietary Supplement: Intermittent zinc supplement Dietary Supplement: Placebo powder Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2886 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double-blind, Community-based Efficacy Trial of Various Doses of Zinc in Micronutrient Powders or Tablets in Young, Bangladeshi Children
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: 1. Standard MNP 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.

Experimental: 2. High zinc, low iron MNP 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.

Experimental: 3. High zinc, low/no iron 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.

Active Comparator: 4. Dispersible zinc supplement Dietary Supplement: Dispersible zinc supplement
10 mg zinc in a dispersible tablet. Daily supplementation for 24 weeks.

Experimental: 5. Intermittent zinc supplement 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.

Placebo Comparator: 6. Placebo powder Dietary Supplement: Placebo powder
Daily provision of a placebo powder for 24 weeks.




Primary Outcome Measures :
  1. Incidence of diarrhea [ Time Frame: Incidence over the 24-week follow-up period ]
    Incidence of diarrhea is defined as the number of diarrheal episodes per person-weeks of follow-up

  2. Change in length-for-age Z score [ Time Frame: Measured at enrollment and the end of the 24-week follow-up period ]
    Change in length-for-age Z score from enrollment to the end of the 24-week follow-up period


Secondary Outcome Measures :
  1. Change in stunting prevalence [ Time Frame: Measured at enrollment and the end of the 24-week follow-up period ]
    Change in the prevalence of stunting (LAZ <-2) in the study population over the 24-week follow-up period

  2. Change in wasting prevalence [ Time Frame: Measured at enrollment and at the end of the 24-week follow-up period ]
    Change in the prevalence of wasting (WLZ <-2) in the study population over the 24-week follow-up period

  3. Incidence of dysentery [ Time Frame: Measured twice weekly for 24 weeks ]
    Dysentery is defined as any diarrheal episode in which the loose or watery stools contain visible red blood

  4. Incidence of diarrhea with dehydration [ Time Frame: Measured twice weekly for 24 weeks ]
    Incidence of diarrhea with dehydration over the 24-week follow-up period

  5. Incidence of hospitalizations [ Time Frame: Assessed twice weekly for 24 weeks ]
    Hospitalization is defined as an overnight stay in the hospital due to illness

  6. Change in mean serum zinc concentration [ Time Frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants ]
    Change in mean serum zinc concentration among children in the biochemistry sub-group over the 24-week follow-up period

  7. Change in the prevalence of zinc deficiency [ Time Frame: Measured at enrollment and at the end of the 24-week follow-up period in subgroup of participants ]
    Change in the prevalence of zinc deficiency (serum zinc concentration <9.9 umol/L) in the biochemistry subgroup from baseline to the end of the 24-week follow-up period



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Ages Eligible for Study:   9 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 9-11 months of age
  • Weight-for-length Z score >= -3 according to the 2006 WHO 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406793


Contacts
Contact: Munir Islam, MBBS, PhD +880 2 982 7001-10 ext 2352 mislam@icddrb.org
Contact: Christine McDonald, ScD 510-450-7938 chmcdonald@chori.org

Locations
Bangladesh
Icddr,B Recruiting
Dhaka, Bangladesh
Contact: Munir Islam, MBBS, PhD    880 2 982 7001-10 ext 2352    mislam@icddrb.org   
Sponsors and Collaborators
Christine McDonald
International Centre for Diarrhoeal Disease Research, Bangladesh
Johns Hopkins Bloomberg School of Public Health
University of Colorado, Denver
Investigators
Principal Investigator: Robert Black, MD, MPH Johns Hopkins Bloomberg School of Public Health

Responsible Party: Christine McDonald, Assistant Scientist, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT03406793     History of Changes
Other Study ID Numbers: 1.05
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christine McDonald, Children's Hospital & Research Center Oakland:
Zinc
Multiple micronutrient powders
Diarrhea
Stunting

Additional relevant MeSH terms:
Diarrhea
Growth Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Pathologic Processes
Iron
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs