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Pilot Feasibility of Rice Bran Supplementation in Children

NCT02557373 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-07-21

No results posted yet for this study

Summary

The purpose of this study is to assess feasibility of rice bran consumption in weaning children and to identify dietary rice bran mediated changes to the stool microbiome and stool metabolome.

Conditions

  • Dietary Rice Bran Supplementation

Interventions

DIETARY_SUPPLEMENT

Vitamin A

100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation.

DIETARY_SUPPLEMENT

Rice Bran + Vitamin A

100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation. Dietary rice bran consumed daily and amounts increase throughout the 3 month intervention (6 months of age: 1 g/day rice bran, 7 months: 2 g/day rice bran, 8 months: 3 g/day)

Sponsors & Collaborators

  • University of the Sciences, Techniques and Technologies of Bamako

    collaborator OTHER

  • Colorado State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
10 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States
  • Mali

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02557373 on ClinicalTrials.gov