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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-06-30

Brief Summary

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

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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. All participants will be given standard, physiological dose of 3 mg zinc sulfate with a zinc stable isotope tracer on study day 8.

On study day 11, 0.5 mg of 13C10-retinyl-acetate will be administered orally to all participants.

Spot urine samples will be collected twice daily from study days 11-14. Complete fecal collections will be obtained for days 11-14. Duplicate diets of all foods consumed will be collected on days 11-14. On study day 14, a blood sample will be taken for analysis of vitamin A isotope status.

Conditions

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Environmental Enteric Dysfunction Zinc Deficiency Vitamin A Deficiency

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with EED

Children are placed in this arm if they screen positive for EED using the urinary lactulose:mannitol (L:M) recovery ratio. Children will receive a one-time 3 mg standard dose of zinc sulfate with stable isotope zinc tracer and 0.5 mg standard dose of 13C10-retinyl-acetate (vitamin A isotope).

3 mg zinc sulfate supplement

Intervention Type DRUG

0.5 mg of 13C10-retinyl-acetate

Intervention Type DRUG

Children without EED

Children are placed in this arm if they screen negative for EED using the urinary lactulose:mannitol (L:M) recovery ratio. Children will receive a one-time 3 mg standard dose of zinc sulfate with stable isotope zinc tracer and 0.5 mg standard dose of 13C10-retinyl-acetate (vitamin A isotope).

3 mg zinc sulfate supplement

Intervention Type DRUG

0.5 mg of 13C10-retinyl-acetate

Intervention Type DRUG

Interventions

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3 mg zinc sulfate supplement

Intervention Type DRUG

0.5 mg of 13C10-retinyl-acetate

Intervention Type DRUG

Other Intervention Names

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Vitamin A isotope

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-score (LAZ) between -1.5 to -3.0
* Hemoglobin (Hgb) ≥ 8

Exclusion Criteria

* Outside age range
* Hgb \< 8
* Chronic illness
* Recent diarrhea (within past 2 weeks, treated with supplemental zinc)
* Severe stunting and/or severe acute malnutrition (SAM): LAZ \<-3; Weight-for-age Z-score (WHZ) \<-3 or mid-upper arm circumference (MUAC) \< 115 or edema

Minimum Eligible Age

18 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes