NCT02758444

Brief Summary

The overall objective is to determine the impact of EED on total daily zinc absorption of young Bangladeshi children (18-24 months of age) in an austere setting with high rates of diarrhea, stunting, and micro-nutrient deficiencies..

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

2.3 years

First QC Date

April 27, 2016

Last Update Submit

July 1, 2019

Conditions

Environmental Enteric DysfunctionZinc Deficiency

Keywords

environmental enteric dysfunctionenvironmental enteropathyzinc absorptionBangladeshtoddlerszinc isotope

Outcome Measures

Primary Outcomes (1)

  • Total daily absorbed zinc (TAZ)

    Measured during the meal to determine the effects of EED on zinc absorption.

    1 day

Secondary Outcomes (16)

  • Exchangeable zinc pool (EZP)

    1 day

  • Plasma zinc

    1 day

  • Alkaline phosphatase

    1 day

  • Serum retinol

    1 day

  • Methyl malonic acid

    1 day

  • +11 more secondary outcomes

Study Arms (4)

Micronutrient Powder (MNP) + 15 mg Zn

ACTIVE COMPARATOR

1 sachet of Micronutrient Powder (MNP) + 15 mg Zn will be added to a single meal on study day 8

Dietary Supplement: Micronutrient Powder (MNP) + 15 mg Zn

MNP + 10 mg Zn

ACTIVE COMPARATOR

1 sachet of MNP + 10 mg Zn will be added to a single meal on study day 8

Dietary Supplement: MNP + 10 mg Zn

MNP + 5 mg Zn

ACTIVE COMPARATOR

1 sachet of MNP + 5 mg Zn will be added to a single meal on study day 8

Dietary Supplement: MNP + 5 mg Zn

MNP without Zn

PLACEBO COMPARATOR

1 sachet of MNP without Zn will be added to a single meal on study day 8

Dietary Supplement: MNP without Zn

Interventions

Micronutrient Powder (MNP) + 15 mg ZnDIETARY_SUPPLEMENT

Children will have the supplement powder added to one meal on study day 1. Absorption of zinc from this meal will be measured using zinc stable isotope techniques.

Micronutrient Powder (MNP) + 15 mg Zn
MNP + 10 mg ZnDIETARY_SUPPLEMENT

Same as above except MNP will contain 10 mg Zn

MNP + 10 mg Zn
MNP + 5 mg ZnDIETARY_SUPPLEMENT

Same as above except MNP will contain 5 mg Zn

MNP + 5 mg Zn
MNP without ZnDIETARY_SUPPLEMENT

Same as above except MNP will not contain Zn

MNP without Zn

Eligibility Criteria

Age18 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Absence of apparent health problems that would impair ability to consume regular diet, to tolerate zinc supplements, or to comply with demands of metabolic studies
  • Length for age Z (LAZ) score between -1.5 to -3.0
  • Hg ≥ 8

You may not qualify if:

  • Outside age range
  • Hb \< 8
  • Chronic illness
  • Zinc supplement within past 2 weeks (including for treatment of diarrhea or MNP containing zinc)
  • Severe stunting and/or severe acute malnutrition (SAM): LAZ \<-3; WHZ \<-3 or MUAC \< 115 or edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

icddr,b (International Centre for Diarrheal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Related Publications (1)

  • Long JM, Mondal P, Westcott JE, Miller LV, Islam MM, Ahmed M, Mahfuz M, Ahmed T, Krebs NF. Zinc Absorption from Micronutrient Powders Is Low in Bangladeshi Toddlers at Risk of Environmental Enteric Dysfunction and May Increase Dietary Zinc Requirements. J Nutr. 2019 Jan 1;149(1):98-105. doi: 10.1093/jn/nxy245.

    PMID: 30624753DERIVED

Study Officials

  • Nancy F Krebs, MD, MS

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 27, 2016

First Posted

May 2, 2016

Study Start

November 1, 2015

Primary Completion

March 1, 2018

Study Completion

February 1, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

Locations

US(1)BA(1)