Clinical trial NCT02758444: Effects of EED on Zn Absorption and Retention in Children From a MNP
Official title: Effects of Environmental Enteric Dysfunction (EED) on Zinc (Zn) Absorption and Retention in Young Children: Study 2 - Absorption of Zn From a Multi-micronutrient Powder (MNP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Enteric Dysfunction
Zinc Deficiency
Keywords: environmental enteric dysfunction
environmental enteropathy
zinc absorption
Bangladesh
toddlers
zinc isotope
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2016-05-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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..

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total daily absorbed zinc (TAZ)
timeFrame: 1 day
Secondary outcomes:
measure: Exchangeable zinc pool (EZP)
timeFrame: 1 day
measure: Plasma zinc
timeFrame: 1 day
measure: Alkaline phosphatase
timeFrame: 1 day
measure: Serum retinol
timeFrame: 1 day
measure: Methyl malonic acid
timeFrame: 1 day
measure: Vitamin B12
timeFrame: 1 day
measure: Serum ferritin
timeFrame: 1 day
measure: Soluble transferrin receptors
timeFrame: 1 day
measure: CRP
timeFrame: 1 day
measure: AGP
timeFrame: 1 day
measure: TNF alpha
timeFrame: 1 day
measure: Serum endocab
timeFrame: 1 day
measure: Neopterin
timeFrame: 1 day
measure: Myeloperoxidase
timeFrame: 1 day
measure: Calprotectin
timeFrame: 1 day
measure: alpha 1 antitrypsin
timeFrame: 1 day
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Dhaka
country: Bangladesh
facility: icddr,b (International Centre for Diarrheal Disease Research, Bangladesh
Study officials:
affiliation: University of Colorado, Denver
name: Nancy F Krebs, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.