Acceptability of a Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement for Children Under Two in Cambodia
Acceptability of a Locally-Produced Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement (LNS) for Children Under Two Years in Cambodia
1 other identifier
interventional
92
1 country
1
Brief Summary
The purpose of this trial is to evaluate the acceptability of the LNS to women and their children aged 12-17 months in comparison to Corn Soy Blend++, and Sprinkles added to borbor (white rice porridge, which is the traditional weaning food in Cambodia). Acceptability will be assessed through a sensory test for caregivers, and by measuring children's consumption.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 6, 2014
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedSeptember 15, 2016
September 1, 2016
1 month
October 2, 2014
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child's consumption
How much of a given food the children consume
Within 15 minutes
Secondary Outcomes (2)
Child's preference
3 days
Mother's ranking
1 session
Study Arms (4)
LNS + borbor
EXPERIMENTALLipid-based nutrient supplement (LNS) added to borbor
Corn-soy blend ++ (CSB++)
ACTIVE COMPARATORCSB++ porridge
Sprinkles
ACTIVE COMPARATORSprinkles added to borbor
LNS snack
ACTIVE COMPARATORLNS eaten as snack
Interventions
Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients.
Blended flour containing soy, corn, milk powder, oil, sugar and multiple micronutrients.
Multiple micronutrient powder packaged in sachet added to borbor (traditional white rice porridge).
Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients added to borbor (traditional white rice porridge).
Eligibility Criteria
You may qualify if:
- Children aged 9-23 months and their caregivers
- Have been eating solids for at least three months
- Singletons
- Normally nourished or only moderately malnourished (MUAC \>115mm, WHZ score \>-3)
- Healthy (no ill-health in past three days)
- No known food intolerances
- Have not been using Sprinkles, CSB++ or similar supplementary foods or supplements
- Informed signed consent of mother
- Mothers are healthy
You may not qualify if:
- Children \<9 months or \>23mths
- Not yet eating solid food for at least three months
- Twins/multiples
- Severely malnourished (MUAC\< 115mm, WHZ score\<3, bipedal pitting oedema).
- Oedema and/or any medical complications at recruitment or illness requiring referral, or any ill health in past three days.
- Known intolerances
- Children enrolled in Sprinkles, CSB++ or similar program
- No informed signed consent of caregiver
- Medical complications or illness requiring referral at time of recruitment or previous two weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRD Cambodia
Phnom Penh, Cambodia
Related Publications (1)
Borg B, Mihrshahi S, Griffin M, Chamnan C, Laillou A, Wieringa FT. Crossover trial to test the acceptability of a locally produced lipid-based nutrient supplement (LNS) for children under 2 years in Cambodia: a study protocol. BMJ Open. 2017 Sep 6;7(9):e015958. doi: 10.1136/bmjopen-2017-015958.
PMID: 28882910DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Frank T Wieringa, MD, PhD
IRD
- PRINCIPAL INVESTIGATOR
Bindi Borg, PhD student
University of Sydney
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Candidate
Study Record Dates
First Submitted
October 2, 2014
First Posted
October 6, 2014
Study Start
June 1, 2015
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
September 15, 2016
Record last verified: 2016-09