Overview

This trial is active, not recruiting.

Condition stunting
Treatment nutrient dense complementary foods
Sponsor SEAMEO Regional Centre for Food and Nutrition
Collaborator Nestlé Foundation
Start date October 2013
End date April 2016
Trial size 217 participants
Trial identifier NCT02532816, Ind_dompustunting

Summary

The purpose of this study is to determine and compare the effect of higher nutrient-dense complementary foods and standard nutrient dense complementary foods on the catch-up growth and nutritional status of stunting children aged 12-23 months old in Indonesia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
subjects will receive nutrient dense complementary foods in optimized CFRs + fortified biscuit (ferrous fumarate 83.5 mg, zinc oxide 50.95 mg, Calcium carbonate 3104.05 mg, Thiamine Mononitrate1.85 mg, Nicotinic Acid 30.45 mg, Pyridoxine Hydrocloride 2.90 mg, Pteroyl monoglutamic acid 764.90 mcg, Cyanocobalamin 0.95 mcg, Retinol Palmitate (dry) 742.50 mcgRE)
nutrient dense complementary foods
Mothers/caregivers will receive optimized CFRs to improve children diets and fortified biscuits (3 types of biscuit) for 6 days per week (in 12 months). Nutrition eduction for mothers/caregivers. Monthly body weight and length/height measurements
(Active Comparator)
subjects will receive nutrient dense complementary foods in optimized CFRs + fortified biscuit (ferrous fumarate 32.6 mg, zinc oxide 3.78 mg, Calcium carbonate 874.12 mg, Thiamine Mononitrate1.25 mg, Nicotinic Acid 17.95 mg, Pyridoxine Hydrocloride 1.10 mg, Pteroyl monoglutamic acid 329.90 mcg, Cyanocobalamin 0.55 mcg)
nutrient dense complementary foods
Mothers/caregivers will receive optimized CFRs to improve children diets and fortified biscuits (3 types of biscuit) for 6 days per week (in 12 months). Nutrition eduction for mothers/caregivers. Monthly body weight and length/height measurements
(Placebo Comparator)
subjects will receive nutrient dense complementary foods in optimized CFRs + non fortified biscuit
nutrient dense complementary foods
Mothers/caregivers will receive optimized CFRs to improve children diets and fortified biscuits (3 types of biscuit) for 6 days per week (in 12 months). Nutrition eduction for mothers/caregivers. Monthly body weight and length/height measurements

Primary Outcomes

Measure
length gain
time frame: one year
linear growth rate
time frame: one year

Eligibility Criteria

Male or female participants from 12 months up to 23 months old.

Inclusion Criteria: - identified as stunting (having HAZ ≤ -2SD of the WHO Growth Standard 2006) - no clinical evidence of any acute infectious disease or other diseases or morbidity condition that could interfere with the intake of study diets - parents and children residence in the study area. - parental concent obtained Exclusion Criteria: - presence of oedema, severe illness warranting hospitalization on the enrolment day such as persistent diarrhea and other disease which may influence feeding practices and nutrient absorption - conncurrent participation in another clinical trial - severe anemia with hemoglobine concentration < 7.0 g/dL

Additional Information

Official title The Effect of Higher Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children in Dompu District, Indonesia
Principal investigator Duma O Fransisca, MSc
Description This is an intervention, double blind study. Investigators want to study the effect of higher nutrient density complementary foods (which consists of optimizing children diet by practicing Optimized Complementary Feeding Recommendation/CFRs and consume special designed fortified biscuit) on catch-up growth and nutritional status of stunting children aged 12 - 23 mos old. There are two phases in this study. Phase I: Development of CFRs and fortified biscuit 1. Food consumption survey (n=100) to gather information on foods typically consumed by the stunting children, food patterns, serving sizes, food price. Methods: 24-hr dietary recall, food weighed dietary records (WDR) and 5-days food tally for each child. Data from food consumption survey will be use to develop optimized CFRs by using Linear Programming (LP) approach with software Optifood v 2.0. Data from LP analysis such as nutrient gaps will be use to formulate fortified biscuit (3 type of nutrient dense). Biscuit ingredients will use local foods. Acceptability trials will be conducted to see the acceptance of the biscuit in the community settings (color, smell, taste and portion). Phase II: Intervention Screening: Anthropometry measurements (body weight and length) to screen stunting and non stunting children; and child with hemoglobine level < 7 g/dL was referred to sub-district health center. Baseline survey: anthropometry measurements (body weight and length), biochemical assessments (3 mL of blood obtain from the antecunital vein for serum zinc, ferritin, transferin receptor, CRP, AGP and RBP), dietary assessment (repeated 24-h recall), socio-demography, food security, health seeking practices questionnaires. Intervention -- optimized CFRs + Biscuits (3 groups) Biscuits will be distributed for 6 days consumption per week (12 months). The waste of the biscuits will be weighted to get actual biscuit consumptions. Mothers/caregivers will be encouraged to practice CFRs to improve child's nutritional adequacy. Monthly body weight and length/height measurement. Nutrition education for mothers/caregivers by field staff. Endline survey: anthropometry measurements (body weight and length), biochemical assessments (3 mL of blood obtain from the antecunital vein for serum zinc, ferritin, transferin receptor, CRP, AGP and RBP), dietary assessment (repeated 24-h recall)
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by SEAMEO Regional Centre for Food and Nutrition.