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

Gadjah Mada University

Status: Unknown

Conditions: Stunting

Treatments: Dietary Supplement: fortified synbiotic milk; Dietary Supplement: non-fortified synbiotic milk

Study type: Interventional

Funder types: Other

Identifiers

NCT03495401

KE/FK/0640/EC/2017

Details and patient eligibility

About

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.

Full 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 L.plantarum 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 .

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age between 2 year to 5 years
• height per age z-score under -2 (stunting)
• parents sign inform consent form

Exclusion criteria

• have congenital abnormality
• lactose intolerant
• use antibiotic for more than 2 weeks
• consume micronutrient supplement (especially iron and zinc) in the last 3 months
• diagnose with chronic diseases and infection that interfere metabolism (i.e. tuberculosis, HIV, autoimmune disease, diabetes mellitus type 1)
• suffer marasmus and/or kwashiorkor
• not willing to continue the intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

fortified synbiotic milk

Experimental group

Description:

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

Treatment:

Dietary Supplement: fortified synbiotic milk

non-fortified synbiotic milk

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: non-fortified synbiotic milk