Effect of Double Fortification (Iron and Zinc) in Synbiotic Milk to Under 5 Years Stunted Children Growth

NCT03495401 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-05-01

No results posted yet for this study

Summary

The purpose of this study is to investigate the effects of double fortification (iron and zinc) in synbiotic milk (L.plantarum Dad13 and fructooligosaccharides) on under 5 years stunted children growth, gut microbiota composition, blood zinc and hemoglobin level, and cognitive level.

Conditions

  • Stunting

Interventions

DIETARY_SUPPLEMENT

fortified synbiotic milk

100 ml fortified (7,47 mg ferrous sulphate and 4,33 mg zinc acetate) synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides

DIETARY_SUPPLEMENT

non-fortified synbiotic milk

100 ml non-fortified synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides

Sponsors & Collaborators

  • Gadjah Mada University

    lead OTHER

Principal Investigators

  • Siti Helmyati, DR. · Gadjah Mada University

  • Lily A. Lestari, DR. · Gadjah Mada University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-28
Primary Completion
2018-09-30
Completion
2018-12-31

Countries

  • Indonesia

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 NCT03495401 on ClinicalTrials.gov