NCT03509155

Food Supplement Treatment for Wasting Children in Indonesia

Status unknown NA Last updated 30 April 2018

What this trial tests

NA trial testing National portion & IYCF counseling in Wasting in 720 participants. Status unknown.

Timeline

1 October 2017

Primary endpoint
31 October 2018

30 November 2018

Quick facts

Lead sponsor	SEAMEO Regional Centre for Food and Nutrition
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	720
Start date	1 October 2017
Primary completion	31 October 2018
Estimated completion	30 November 2018
Sites	1 location across Indonesia

Drugs / interventions tested

• National portion & IYCF counseling
• Adjusted portion & local food counseling

Conditions studied

• Wasting — all drugs for Wasting →
• Nutrition Disorder, Child — all drugs for Nutrition Disorder, Child →

Sponsor

SEAMEO Regional Centre for Food and Nutrition

Who can join

Adults 6 Months to 23 Months, any sex, with Wasting or Nutrition Disorder, Child. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Assessing program efficacy of under five food supplementation (PMT Biscuits) is needed after the first 6 months of exclusive breastfeeding, children were introduced to liquid and semi-solid food. In this phase of food introduction, children ability to accept food supplementation program was still questionable and the efficacy needs to be assessed.

Another aspect that needed to be evaluated is assessing the efficacy of food supplementation to improve the nutritional status of wasting children in multiple cities to describe Indonesian geographical and socio-economic diversity (multi center studies). PMT biscuits supplementation intervention is accompanied by educational modules on Infant and Young Child Feeding (IYCF) in order to improve caregiver's knowledge and skills in providing economically affordable and nutritious food for their children. PMT biscuits supplementation evaluation will be assessed at 9 months observations (3 months intervals). The observation will be conducted every month up until the first 3 months then the observation will be continued in 6th and 9th months of observation.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of an Integrated Nutrition Rehabilitation on Growth and Development of Children under Five Post 2018 Earthquake in East Lombok, Indonesia.
   Fahmida U, Hidayat AT, Oka AASI, Suciyanti D, et al · · 2022 · cited 11× · PMID 35270504 · DOI 10.3390/ijerph19052814
2. A multicentre randomized controlled trial of food supplement intervention for wasting children in Indonesia-study protocol.
   Kekalih A, Anak Agung Sagung IO, Fahmida U, Ermayani E, et al · · 2019 · cited 3× · PMID 30866888 · DOI 10.1186/s12889-019-6608-5