Environmental Enteric Dysfunction, Zinc Deficiency
Conditions
Keywords
environmental enteric dysfunction, environmental enteropathy, zinc absorption, Bangladesh, toddlers, zinc isotope
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.
Interventions
DIETARY_SUPPLEMENTMicronutrient 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.
DIETARY_SUPPLEMENTMNP without Zn
Same as above except MNP will not contain Zn
DIETARY_SUPPLEMENTMNP + 10 mg Zn
Same as above except MNP will contain 10 mg Zn
DIETARY_SUPPLEMENTMNP + 5 mg Zn
Same as above except MNP will contain 5 mg Zn
Sponsors
International Centre for Diarrhoeal Disease Research, Bangladesh
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 24 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total daily absorbed zinc (TAZ) | 1 day | Measured during the meal to determine the effects of EED on zinc absorption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum retinol | 1 day | Measured prior to the meal. |
| Methyl malonic acid | 1 day | Measured prior to the meal. |
| Vitamin B12 | 1 day | Measured prior to the meal. |
| Serum ferritin | 1 day | Measured prior to the meal. |
| Soluble transferrin receptors | 1 day | Measured prior to the meal. |
| CRP | 1 day | Measured prior to the meal. |
| AGP | 1 day | Measured prior to the meal. |
| Alkaline phosphatase | 1 day | Measured prior to the meal. |
| Serum endocab | 1 day | Measured prior to the meal. |
| Neopterin | 1 day | Measured prior to the meal. |
| Myeloperoxidase | 1 day | Measured prior to the meal. |
| Calprotectin | 1 day | Measured prior to the meal. |
| alpha 1 antitrypsin | 1 day | Measured prior to the meal. |
| Exchangeable zinc pool (EZP) | 1 day | Size of exchangeable Zn pool (EZP) measured with zinc isotope methods prior to the meal. |
| Plasma zinc | 1 day | Measured prior to the meal. |
| TNF alpha | 1 day | Measured prior to the meal. |
Countries
Bangladesh, United States
Outcome results
None listed