Effects of EED on Zn Absorption and Retention in Children From a MNP

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Environmental Enteric Dysfunction, Zinc Deficiency

Intervention / Treatment
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* Dietary Supplement: Micronutrient Powder (MNP) + 15 mg Zn
* Dietary Supplement: MNP + 10 mg Zn
* Dietary Supplement: MNP + 5 mg Zn
* Dietary Supplement: MNP without Zn


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Micronutrient Powder (MNP) + 15 mg Zn<br>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<br>* 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.<br>|
| Active Comparator: MNP + 10 mg Zn<br>1 sachet of MNP + 10 mg Zn will be added to a single meal on study day 8 | Dietary Supplement: MNP + 10 mg Zn<br>* Same as above except MNP will contain 10 mg Zn<br>|
| Active Comparator: MNP + 5 mg Zn<br>1 sachet of MNP + 5 mg Zn will be added to a single meal on study day 8 | Dietary Supplement: MNP + 5 mg Zn<br>* Same as above except MNP will contain 5 mg Zn<br>|
| Placebo Comparator: MNP without Zn<br>1 sachet of MNP without Zn will be added to a single meal on study day 8 | Dietary Supplement: MNP without Zn<br>* Same as above except MNP will not contain Zn<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total daily absorbed zinc (TAZ) | Measured during the meal to determine the effects of EED on zinc absorption. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exchangeable zinc pool (EZP) | Size of exchangeable Zn pool (EZP) measured with zinc isotope methods prior to the meal. | 1 day | 
| Plasma zinc | Measured prior to the meal. | 1 day | 
| Alkaline phosphatase | Measured prior to the meal. | 1 day | 
| Serum retinol | Measured prior to the meal. | 1 day | 
| Methyl malonic acid | Measured prior to the meal. | 1 day | 
| Vitamin B12 | Measured prior to the meal. | 1 day | 
| Serum ferritin | Measured prior to the meal. | 1 day | 
| Soluble transferrin receptors | Measured prior to the meal. | 1 day | 
| CRP | Measured prior to the meal. | 1 day | 
| AGP | Measured prior to the meal. | 1 day | 
| TNF alpha | Measured prior to the meal. | 1 day | 
| Serum endocab | Measured prior to the meal. | 1 day | 
| Neopterin | Measured prior to the meal. | 1 day | 
| Myeloperoxidase | Measured prior to the meal. | 1 day | 
| Calprotectin | Measured prior to the meal. | 1 day | 
| alpha 1 antitrypsin | Measured prior to the meal. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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environmental enteric dysfunction, environmental enteropathy, zinc absorption, Bangladesh, toddlers, zinc isotope