Effects of EED on Zn Absorption and Retention in Children From a MNP (ZEED2)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Zinc Deficiency; Environmental Enteric Dysfunction

Treatments: Dietary Supplement: MNP + 10 mg Zn; Dietary Supplement: MNP without Zn; Dietary Supplement: MNP + 5 mg Zn; Dietary Supplement: Micronutrient Powder (MNP) + 15 mg Zn

Study type: Interventional

Funder types: Other

Identifiers

NCT02758444

14-2430B

Details and patient eligibility

About

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..

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 24 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

Micronutrient Powder (MNP) + 15 mg Zn

Active Comparator group

Description:

1 sachet of Micronutrient Powder (MNP) + 15 mg Zn will be added to a single meal on study day 8

Treatment:

Dietary Supplement: Micronutrient Powder (MNP) + 15 mg Zn

MNP + 10 mg Zn

Active Comparator group

Description:

1 sachet of MNP + 10 mg Zn will be added to a single meal on study day 8

Treatment:

Dietary Supplement: MNP + 10 mg Zn

MNP + 5 mg Zn

Active Comparator group

Description:

1 sachet of MNP + 5 mg Zn will be added to a single meal on study day 8

Treatment:

Dietary Supplement: MNP + 5 mg Zn

MNP without Zn

Placebo Comparator group

Description:

1 sachet of MNP without Zn will be added to a single meal on study day 8

Treatment:

Dietary Supplement: MNP without Zn