Try our beta test site
Trial record 1 of 1 for:    NCT02257762
Previous Study | Return to List | Next Study

Efficacy of a Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement for Children Under Two in Cambodia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
UNICEF
Fisheries Post Harvest Technologies and Quality, Cambodia
Information provided by (Responsible Party):
Bindi Borg, University of Sydney
ClinicalTrials.gov Identifier:
NCT02257762
First received: October 2, 2014
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
The purpose of this trial is to evaluate the efficacy of the LNS on children aged 6-17 months in preventing growth faltering and improving micronutrient status. The impact of product will be compared to Corn Soy Blend ++ (CSB++), Sprinkles, and to a control group consuming an unsupplemented diet, which is usually borbor at an early age, and thereafter, family foods.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy 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 Institut de Recherche pour le Developpement, Cambodia:

Primary Outcome Measures:
  • Nutritional status [ Time Frame: 6 months ]
    Weight-for-height (WHZ), length/height-for-age (L/HAZ), and weight-for-age (WAZ) calculated through monthly weight and height measurements


Secondary Outcome Measures:
  • Body composition [ Time Frame: 6 months ]
    Triceps, biceps and/or subscapular skinfolds

  • Iron status [ Time Frame: 6 months ]
    Analysis of haemoglobin (g/l), ferritin (µg/l), tranferrin receptor (mg/l), C reactive protein (mg/l), and alpha-1-acid glycoprotein (mg/l)


Enrollment: 487
Study Start Date: February 2016
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lipid-based nutrient supplement (LNS)
LNS added to borbor, eaten over 6 months, age 6-12 months to age 11-17 months
Dietary Supplement: LNS
Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients
Active Comparator: Corn-soy blend ++ (CSB++)
CSB++ porridge, eaten over 6 months, age 6-12 months to age 11-17 months
Dietary Supplement: Corn-soy blend ++ (CSB++)
Blended flour containing soy, corn, milk powder, oil, sugar and multiple micronutrients.
Other Name: Supercereal Plus
Active Comparator: Sprinkles
Sprinkles added to borbor, eaten over 6 months, age 6-12 months to age 11-17 months
Dietary Supplement: Sprinkles
Multiple micronutrient powder packaged in sachet.
No Intervention: Control
Plain borbor and thereafter family foods, eaten over 6 months, age 6-12 months to age 11-17 months

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children aged 6-12 months
  • Normally nourished or only moderately malnourished (MUAC>115mm, WHZ score>-3)
  • Have not received therapy for acute malnutrition within one month prior to presentation
  • Healthy (no ill-health in past two weeks)
  • Anaemia status - normal, mild or moderate
  • No known food intolerances
  • Informed signed consent of caregiver
  • Caregivers are healthy

Exclusion Criteria:

  • Children <6 months or >12mths
  • Severely malnourished (MUAC< 115mm, WHZ score<3, bipedal pitting oedema).
  • Have received therapy for acute malnutrition within one month prior to presentation
  • Any medical complications at the recruitment time or illness requiring referral or clinic visit in past 2 weeks
  • Severe anaemia (Hb<70g/l)
  • Known intolerances
  • No informed signed consent of caregiver
  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: NCT02257762

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, MA,PhD cand. University of Sydney
  More Information

Responsible Party: Bindi Borg, PhD Candidate, University of Sydney
ClinicalTrials.gov Identifier: NCT02257762     History of Changes
Other Study ID Numbers: LNS-CAMB-INFANTS-EFF
Study First Received: October 2, 2014
Last Updated: September 13, 2016

Keywords provided by Institut de Recherche pour le Developpement, Cambodia:
Ready-to-use supplementary food (RUSF)
Lipid-based nutrient supplement (LNS)
Multiple micronutrients (MMN)
Complementary feeding
Home fortification
Efficacy/impact
Infant and young child feeding (IYCF)
Cambodia
Cluster randomised controlled trial

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 March 29, 2017