StuntingNCT02532816
Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children
A study testing Nutrient dense complementary foods in people with Stunting, run by SEAMEO Regional Centre for Food and Nutrition at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Stunting
- What is being tested?
- Nutrient dense complementary foods
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 1 siteIndonesia
- Study dates
- Oct 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
in the community (Woja,Manggelewa, Kempo subdistrict)
Dompu, West Nusa Tenggara
About this study
Official title: The Effect of Higher Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children in Dompu District, Indonesia
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.
Read the 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
- 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)
- Conditions
- Stunting
- Being tested
- Nutrient dense complementary foods
- Keywords
- stunting, indonesia
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Dietary Supplement: Nutrient dense complementary foods |
| NDN-CF | Placebo comparator | subjects will receive nutrient dense complementary foods in optimized CFRs + non fortified biscuit Receives: Dietary Supplement: Nutrient dense complementary foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
length gain
The increment of body length/height of the subjects, monthly measurement
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startOct 2013
- Primary completionApr 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StuntingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEAMEO Regional Centre for Food and Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Foundation, Universitas Indonesia, Institut Pertanian Bogor, London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Duma Octavia Fransisca, MSc, SEAMEO Regional Centre for Food and Nutrition
- Investigators
- Duma O Fransisca, MSc, Principal investigator, SEAMEO Regional Centre for Food and NutritionUmi Fahmida, Dr, Principal investigator, SEAMEO Regional Centre for Food and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532816
- Sponsor's protocol ID
- Ind_dompustunting
- Status last verified
- Aug 2015
- First submitted
- 20 Aug 2015
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Golden MH. Proposed recommended nutrient densities for moderately malnourished children. Food Nutr Bull. 2009 Sep;30(3 Suppl):S267-342. doi: 10.1177/15648265090303S302.
PubMed 19998863Ferguson 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.
PubMed 15051853
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Higher Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children in Dompu District, Indonesia
- ClinicalTrials.gov ID
- NCT02532816
- Acronym / sponsor ID
- Ind_dompustunting
- Conditions
- Stunting
- Keywords
- stunting, indonesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 217 participants (actual)
- Lead sponsor
- SEAMEO Regional Centre for Food and NutritionUniversity, hospital or other
- Collaborators
- Nestlé Foundation, Universitas Indonesia, Institut Pertanian Bogor, London School of Hygiene and Tropical Medicine
- Study start
- Oct 2013
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HND-CF | Experimental | Dietary Supplement: Nutrient dense complementary foodssubjects 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) |
| SND-CF | Active comparator | Dietary Supplement: Nutrient dense complementary foodssubjects 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) |
| NDN-CF | Placebo comparator | Dietary Supplement: Nutrient dense complementary foodssubjects will receive nutrient dense complementary foods in optimized CFRs + non fortified biscuit |
Who may qualify
- Ages
- 12 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrient dense complementary foodsMothers/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 | Dietary supplement | HND-CF, NDN-CF, SND-CF |
Primary outcome
length gain
Time frame: one year
The increment of body length/height of the subjects, monthly measurement
linear growth rate
Time frame: one year
growth velocity = (x2-x1)/(t2-t1) where x2 and x1 are values of the measurement on two occacions t2 and t1. in mm/d
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Background: PubMed 19998863Golden MH. Proposed recommended nutrient densities for moderately malnourished children. Food Nutr Bull. 2009 Sep;30(3 Suppl):S267-342. doi: 10.1177/15648265090303S302.
- Background: PubMed 15051853Ferguson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duma O Fransisca, MSc principal investigator
SEAMEO Regional Centre for Food and Nutrition
Umi Fahmida, Dr principal investigator
SEAMEO Regional Centre for Food and Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrient dense complementary foods in people with Stunting, run by SEAMEO Regional Centre for Food and Nutrition at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length gain (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02532816, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.