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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02758444
Other study ID # 14-2430B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2015
Est. completion date February 2019

Study information

Verified date July 2019
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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..


Description:

Participating children are screened for EED using the lactulose:mannitol ratio test and assigned to one of two groups: +EED or -EED. After assignment to one of the two groups, proposed subjects will be randomized to one of four supplement groups: Micronutrient powder (MNP) with 15 mg Zn, MNP with 10 mg Zn, MNP with 5 mg Zn, and MNP with 0 mg Zn. Children will receive the supplement once with a meal on Day 8 of the study. Absorption of zinc from the supplement and from other non-supplemented meals will be determined using zinc stable isotope technology.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date February 2019
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Months to 24 Months
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Micronutrient Powder (MNP) + 15 mg Zn
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.
MNP + 10 mg Zn
Same as above except MNP will contain 10 mg Zn
MNP + 5 mg Zn
Same as above except MNP will contain 5 mg Zn
MNP without Zn
Same as above except MNP will not contain Zn

Locations

Country Name City State
Bangladesh icddr,b (International Centre for Diarrheal Disease Research, Bangladesh Dhaka
United States University of Colorado Denver Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver International Centre for Diarrhoeal Disease Research, Bangladesh

Countries where clinical trial is conducted

United States,  Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total daily absorbed zinc (TAZ) Measured during the meal to determine the effects of EED on zinc absorption. 1 day
Secondary Exchangeable zinc pool (EZP) Size of exchangeable Zn pool (EZP) measured with zinc isotope methods prior to the meal. 1 day
Secondary Plasma zinc Measured prior to the meal. 1 day
Secondary Alkaline phosphatase Measured prior to the meal. 1 day
Secondary Serum retinol Measured prior to the meal. 1 day
Secondary Methyl malonic acid Measured prior to the meal. 1 day
Secondary Vitamin B12 Measured prior to the meal. 1 day
Secondary Serum ferritin Measured prior to the meal. 1 day
Secondary Soluble transferrin receptors Measured prior to the meal. 1 day
Secondary CRP Measured prior to the meal. 1 day
Secondary AGP Measured prior to the meal. 1 day
Secondary TNF alpha Measured prior to the meal. 1 day
Secondary Serum endocab Measured prior to the meal. 1 day
Secondary Neopterin Measured prior to the meal. 1 day
Secondary Myeloperoxidase Measured prior to the meal. 1 day
Secondary Calprotectin Measured prior to the meal. 1 day
Secondary alpha 1 antitrypsin Measured prior to the meal. 1 day
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