NCT02532816

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

2.5 years

First QC Date

August 20, 2015

Last Update Submit

August 21, 2015

Conditions

Stunting

Keywords

stuntingindonesia

Outcome Measures

Primary Outcomes (2)

  • length gain

    The increment of body length/height of the subjects, monthly measurement

    one year

  • 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

    one year

Study Arms (3)

HND-CF

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)

Dietary Supplement: Nutrient dense complementary foods

SND-CF

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)

Dietary Supplement: Nutrient dense complementary foods

NDN-CF

PLACEBO COMPARATOR

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

Dietary Supplement: Nutrient dense complementary foods

Interventions

Nutrient dense complementary foodsDIETARY_SUPPLEMENT

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

HND-CFNDN-CFSND-CF

Eligibility Criteria

Age12 Months - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

in the community (Woja,Manggelewa, Kempo subdistrict)

Dompu, West Nusa Tenggara, Indonesia

Location

Related Publications (2)

  • Golden MH. Proposed recommended nutrient densities for moderately malnourished children. Food Nutr Bull. 2009 Sep;30(3 Suppl):S267-342. doi: 10.1177/15648265090303S302.

    PMID: 19998863BACKGROUND

  • 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.

    PMID: 15051853BACKGROUND

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Duma O Fransisca, MSc

    SEAMEO Regional Centre for Food and Nutrition

    PRINCIPAL INVESTIGATOR

  • Umi Fahmida, Dr

    SEAMEO Regional Centre for Food and Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

August 20, 2015

First Posted

August 26, 2015

Study Start

October 1, 2013

Primary Completion

April 1, 2016

Study Completion

July 1, 2016

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

ID(1)