Viewing Study NCT03495401



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Last Modification Date: 2024-10-26 @ 12:43 PM
Study NCT ID: NCT03495401
Status: UNKNOWN
Last Update Posted: 2018-05-01
First Post: 2018-03-04

Brief Title: Effect of Double Fortification Iron and Zinc in Synbiotic Milk to Under 5 Years Stunted Children Growth
Sponsor: Gadjah Mada University
Organization: Gadjah Mada University

Study Overview

Official Title: Effect of Double Fortification Iron and Zinc in Synbiotic Milk to Under 5 Years Stunted Children Growth the Efforts to Achieve Target 2 SDGs Utilizing Local Natural Resources
Status: UNKNOWN
Status Verified Date: 2018-04
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to investigate the effects of double fortification iron and zinc in synbiotic milk Lplantarum Dad13 and fructooligosaccharides on under 5 years stunted children growth gut microbiota composition blood zinc and hemoglobin level and cognitive level
Detailed Description: This is a parallel quadruple-blind randomized controlled trial to determine the effects of double fortification iron and zinc in synbiotic milk containing 7 billion CFU Lplantarum Dad13 and 4 g fructooligosaccharides on the gut microbiota composition body height and weight blood zinc and hemoglobin level and cognitive level in under 5 years stunted children subjects The duration of the study is 4 months including a 2-week pre test and informed consent before randomization of subjects into treatment or control group a 12-week intervention period and a 2-week post test after the end of intervention During the intervention period subjects will be instructed to take 100 ml of fortified synbiotic milk or non-fortified synbiotic milk per day They will also be asked to document consumed milk any unusual symptoms or side effects of treatment Diet will be monitored via 24-h dietary recalls and SQ-FFQ before and after treatment respectively Changes in the gut microbiota composition will be determined by measuring bacterial population levels Bifidobacteria Lactobacillus Enterobacteria Prevotella and Bacteroides in stool sampled collected at baseline and 12 weeks by qPCR Metabolic markers calprotectin hemoglobin and zinc level will be measured at baseline and 12-weeks in serum and plasma using biochemical and immuno-assay Changes in the cognitive level height for age Z-score collected at baseline and 12 weeks using Bayley Scales of Infant Development 2nd Edition

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None