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Trial record 1 of 1 for:    NCT02257437
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Acceptability of a Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement for Children Under Two in Cambodia

This study has been completed.
Sponsor:
Collaborators:
UNICEF
Fisheries Post Harvest Technologies and Quality, Cambodia
Information provided by (Responsible Party):
Bindi Borg, University of Sydney
ClinicalTrials.gov Identifier:
NCT02257437
First received: October 2, 2014
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Child Malnutrition Dietary Supplement: LNS snack Dietary Supplement: Corn-soy blend ++ (CSB++) Dietary Supplement: Sprinkles Dietary Supplement: LNS + borbor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Acceptability of a Locally-Produced Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement (LNS) for Children Under Two Years in Cambodia

Resource links provided by NLM:


Further study details as provided by Bindi Borg, University of Sydney:

Primary Outcome Measures:
  • Child's consumption [ Time Frame: Within 15 minutes ]
    How much of a given food the children consume


Secondary Outcome Measures:
  • Child's preference [ Time Frame: 3 days ]
    Mothers' assessment of their child's ranked preference for the food

  • Mother's ranking [ Time Frame: 1 session ]
    Mother's ranked preference for the food


Enrollment: 92
Study Start Date: June 2015
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LNS + borbor
Lipid-based nutrient supplement (LNS) added to borbor
Dietary Supplement: LNS snack
Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients.
Dietary Supplement: Corn-soy blend ++ (CSB++)
Blended flour containing soy, corn, milk powder, oil, sugar and multiple micronutrients.
Other Name: Supercereal Plus
Dietary Supplement: Sprinkles
Multiple micronutrient powder packaged in sachet added to borbor (traditional white rice porridge).
Dietary Supplement: LNS + borbor
Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients added to borbor (traditional white rice porridge).
Active Comparator: Corn-soy blend ++ (CSB++)
CSB++ porridge
Dietary Supplement: LNS snack
Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients.
Dietary Supplement: Corn-soy blend ++ (CSB++)
Blended flour containing soy, corn, milk powder, oil, sugar and multiple micronutrients.
Other Name: Supercereal Plus
Dietary Supplement: Sprinkles
Multiple micronutrient powder packaged in sachet added to borbor (traditional white rice porridge).
Dietary Supplement: LNS + borbor
Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients added to borbor (traditional white rice porridge).
Active Comparator: Sprinkles
Sprinkles added to borbor
Dietary Supplement: LNS snack
Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients.
Dietary Supplement: Corn-soy blend ++ (CSB++)
Blended flour containing soy, corn, milk powder, oil, sugar and multiple micronutrients.
Other Name: Supercereal Plus
Dietary Supplement: Sprinkles
Multiple micronutrient powder packaged in sachet added to borbor (traditional white rice porridge).
Dietary Supplement: LNS + borbor
Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients added to borbor (traditional white rice porridge).
Active Comparator: LNS snack
LNS eaten as snack
Dietary Supplement: LNS snack
Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients.
Dietary Supplement: Corn-soy blend ++ (CSB++)
Blended flour containing soy, corn, milk powder, oil, sugar and multiple micronutrients.
Other Name: Supercereal Plus
Dietary Supplement: Sprinkles
Multiple micronutrient powder packaged in sachet added to borbor (traditional white rice porridge).
Dietary Supplement: LNS + borbor
Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients added to borbor (traditional white rice porridge).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   9 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02257437

Locations
Cambodia
IRD Cambodia
Phnom Penh, Cambodia
Sponsors and Collaborators
Institut de Recherche pour le Developpement, Cambodia
UNICEF
Fisheries Post Harvest Technologies and Quality, Cambodia
Investigators
Study Director: Frank T Wieringa, MD, PhD IRD
Principal Investigator: Bindi Borg, PhD student University of Sydney
  More Information

Responsible Party: Bindi Borg, PhD Candidate, University of Sydney
ClinicalTrials.gov Identifier: NCT02257437     History of Changes
Other Study ID Numbers: LNS-CAMB-INFANTS
Study First Received: October 2, 2014
Last Updated: September 13, 2016

Keywords provided by Bindi Borg, University of Sydney:
Ready-to-use supplementary food (RUSF)
Lipid-based nutrient supplement (LNS)
Multiple micronutrients (MMN)
Complementary feeding
Home fortification
Acceptability
Infant and young child feeding (IYCF)
Cambodia
Cross-over studies

Additional relevant MeSH terms:
Malnutrition
Child Nutrition Disorders
Nutrition Disorders
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017