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Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children

Primary Purpose

Stunting

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Nutrient dense complementary foods
Sponsored by
SEAMEO Regional Centre for Food and Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stunting focused on measuring stunting, indonesia

Eligibility Criteria

12 Months - 23 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • in the community (Woja,Manggelewa, Kempo subdistrict)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

HND-CF

SND-CF

NDN-CF

Arm Description

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)

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)

subjects will receive nutrient dense complementary foods in optimized CFRs + non fortified biscuit

Outcomes

Primary Outcome Measures

length gain
The increment of body length/height of the subjects, monthly measurement
linear growth rate
growth velocity = (x2-x1)/(t2-t1) where x2 and x1 are values of the measurement on two occacions t2 and t1. in mm/d

Secondary Outcome Measures

Full Information

First Posted
August 20, 2015
Last Updated
August 21, 2015
Sponsor
SEAMEO Regional Centre for Food and Nutrition
Collaborators
Nestlé Foundation, Indonesia University, Institut Pertanian Bogor, London School of Hygiene and Tropical Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02532816
Brief Title
Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children
Official Title
The Effect of Higher Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children in Dompu District, Indonesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SEAMEO Regional Centre for Food and Nutrition
Collaborators
Nestlé Foundation, Indonesia University, Institut Pertanian Bogor, London School of Hygiene and Tropical Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stunting
Keywords
stunting, indonesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HND-CF
Arm Type
Experimental
Arm Description
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)
Arm Title
SND-CF
Arm Type
Active Comparator
Arm Description
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)
Arm Title
NDN-CF
Arm Type
Placebo Comparator
Arm Description
subjects will receive nutrient dense complementary foods in optimized CFRs + non fortified biscuit
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrient dense complementary foods
Intervention Description
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 Outcome Measure Information:
Title
length gain
Description
The increment of body length/height of the subjects, monthly measurement
Time Frame
one year
Title
linear growth rate
Description
growth velocity = (x2-x1)/(t2-t1) where x2 and x1 are values of the measurement on two occacions t2 and t1. in mm/d
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duma O Fransisca, MSc
Organizational Affiliation
SEAMEO Regional Centre for Food and Nutrition
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Umi Fahmida, Dr
Organizational Affiliation
SEAMEO Regional Centre for Food and Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
in the community (Woja,Manggelewa, Kempo subdistrict)
City
Dompu
State/Province
West Nusa Tenggara
Country
Indonesia

12. IPD Sharing Statement

Citations:
PubMed Identifier
19998863
Citation
Golden MH. Proposed recommended nutrient densities for moderately malnourished children. Food Nutr Bull. 2009 Sep;30(3 Suppl):S267-342. doi: 10.1177/15648265090303S302.
Results Reference
background
PubMed Identifier
15051853
Citation
Ferguson EL, Darmon N, Briend A, Premachandra IM. Food-based dietary guidelines can be developed and tested using linear programming analysis. J Nutr. 2004 Apr;134(4):951-7. doi: 10.1093/jn/134.4.951.
Results Reference
background

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Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children

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