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Completed

NCT Number: NCT03406793

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

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.

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Key information

Conditions

Diarrhea Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stunting

Age range

9 month–11 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icddr,B

Dhaka, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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.

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.

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.

Dispersible zinc supplement

Dietary Supplement

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

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.

Placebo Powder

Dietary Supplement

Daily provision of a placebo powder for 24 weeks.

Primary outcomes

  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 outcomes

  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 in all 6 intervention groups

    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 in all 6 intervention groups

    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

  8. Change in the exchangeable zinc pool size

    Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.

    Change in the exchangeable zinc pool size from enrollment to the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP group, dispersible zinc supplement group, and placebo group

  9. Change in ferritin concentrations

    Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants in all 6 intervention groups

    Change in mean concentrations of ferritin from enrollment to the end of the 24-week follow-up period among participants in the biochemistry subgroup.

  10. Change in concentrations of soluble transferrin receptor

    Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants in all 6 intervention groups

    Change in mean concentrations of soluble transferrin receptor from enrollment to the end of the 24-week follow-up period among participants in the biochemistry subgroup.

  11. Change in gut microbiota

    Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.

    Change in the composition of gut microbiota from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron; dispersible zinc supplement; and placebo powder groups.

  12. Change in amino acid metabolites associated with gut permeability

    Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.

    To compare the change in amino acid metabolites associated with gut permeability from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron MNP; dispersible zinc supplement; and placebo groups.

  13. Change in lipid metabolites associated with gut permeability

    Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.

    To compare the change in lipid metabolites associated with gut permeability from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron MNP; dispersible zinc supplement; and placebo groups.

  14. Change in genome wide gene expression by RNA-sequencing

    Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.

    To compare the change in genome wide gene expression, measured with RNA-sequencing, from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron MNP; dispersible zinc supplement; and placebo groups.

  15. Change in specific gene expression by quantitative Polymerase Chain Reaction

    Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.

    To compare the change in specific gene expression, measured by quantitative Polymerase Chain Reaction, from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron MNP; dispersible zinc supplement; and placebo groups.

  16. Change in cellular immune function by leukocyte profiles

    Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.

    To compare the change in cellular immune function by leukocyte profiles, from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron MNP; dispersible zinc supplement; and placebo groups.

  17. Change in serum cytokines

    Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.

    To compare the change in serum cytokines, measured by Luminex analysis, from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron MNP; dispersible zinc supplement; and placebo groups.

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Johns Hopkins Bloomberg School of Public Health
  • University of Colorado, Denver

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2018
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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