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

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ClinicalTrials.gov Identifier: NCT02257762
Recruitment Status : Unknown
Verified September 2016 by Bindi Borg, University of Sydney.
Recruitment status was:  Active, not recruiting
First Posted : October 6, 2014
Last Update Posted : September 15, 2016
Sponsor:
Collaborators:
UNICEF
Department of Fisheries Post-harvest Technologies and Quality Control
Information provided by (Responsible Party):
Bindi Borg, University of Sydney

Tracking Information
First Submitted Date  ICMJE October 2, 2014
First Posted Date  ICMJE October 6, 2014
Last Update Posted Date September 15, 2016
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
Nutritional status [ Time Frame: 9 months ]
Weight-for-height (WHZ), length/height-for-age (L/HAZ), and weight-for-age (WAZ) calculated through monthly weight and height measurements
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2016)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
  • Body composition [ Time Frame: 9 months ]
    Triceps, biceps and/or subscapular skinfolds
  • Iron status [ Time Frame: 9 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of a Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement for Children Under Two in Cambodia
Official Title  ICMJE Efficacy of a Locally-Produced Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement (LNS) for Children Under Two Years in Cambodia
Brief Summary 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.
Detailed Description

BACKGROUND:

In Cambodia, progress in combatting malnutrition has stalled. In 2010, 40% of all children under five (and 49% of 4-5 year-olds) were stunted, 11% were wasted, and 28% were underweight, indicating, respectively, chronic and acute malnutrition, and a combination of the two. Stunting is partially attributed to poor complementary feeding, which remains inadequate for achieving growth outcomes and micronutrient status.

Malnutrition can be prevented with supplementary foods. These foods usually contain a source of protein and lipids such as powered milk, soy or peanuts, and multiple micronutrients. They can be prepared as a fortified blended product, such as Corn-Soy Blend++ (CSB++), that is mixed with water to make a porridge, or ready-to-use supplementary foods (RUSFs). The latter are usually lipid-based nutrient supplements (LNSs) which are often pastes such as the peanut-based Plumpy'Nut™. These energy-dense supplementary foods contain both macro and micronutrients and are used to prevent and treat moderate acute malnutrition by promoting improved linear growth, weight gain and micronutrient status among children. Until recently, treatment of moderate acute malnutrition has relied on fortified blended products. The new RUSFs are also proving effective, as they are higher energy and have a longer shelf life, and since they require no preparation, are convenient. Another common nutrition intervention is multiple micronutrient supplements such as Sprinkles. These are individually-packed powders that can be added to food. However, micronutrients are more likely to achieve growth outcomes when they are combined with energy, for example, in lipid-based nutrient supplements and there is no evidence that micronutrient powders alone contribute to growth.

Until June 2014, the United Nations World Food Program (WFP) used CSB++ (now called Supercereal Plus) to treat and prevent moderate acute malnutrition in Cambodia. Sprinkles are also being distributed, though not widely, to prevent micronutrient deficiencies. These products that have been recently or are currently used are relatively expensive to procure and ship to Cambodia and in the case of Sprinkles, are not as effective as foods that contain macronutrients. Moreover, CSB++ was not very well accepted in practice, and WFP has phased it out. Therefore, UNICEF and the Cambodian Ministry of Health are looking for a locally-produced product containing macro and micronutrients to prevent growth faltering and improve micronutrient status in Cambodian children.

TRIAL DESIGN AND METHODOLOGY:

Therefore, this trial will evaluate the efficacy of the LNS on children aged 6-17 months in preventing growth faltering and improving micronutrient statu. The impact of product will be compared to CSB++, Sprinkles, and to a control group.

The trial is a prospective, cluster randomised, non-blinded controlled trial among infants 6-17 months of age. The trial aims to establish the superiority of the novel LNS, using CSB++ and Sprinkles as active comparators and the unimproved diet as a control. The allocation ratio is 1:1. The study will take place over 8 months.

The study will be conducted in 28 sites in peri-urban Phnom Penh. Infants aged 6-12 months will be recruited. Upon consent and enrolment, baseline data will be collected from the participants. This will include demographics, morbidity, anthropometry (weight, height, mid-upper arm circumference, skinfolds), haematological and stool samples, dietary data (breastfeeding, food frequency and dietary diversity). Data will be collected monthly, and haematological samples will be collected again at endline.

Participants will then be provided with a one month supply of the food to which their site has been allocated. Staff will explain how to prepare the food, how often it should be consumed, and who should consume it (i.e. subjects). Participants will be provided with food on a monthly basis. They will continue to consume the food over a six-month period, at which time endline data, including haematological samples, will be collected.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Child Malnutrition
Intervention  ICMJE
  • Dietary Supplement: LNS
    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.
Study Arms  ICMJE
  • Experimental: Lipid-based nutrient supplement (LNS)
    LNS added to borbor, eaten over 6 months, age 6-12 months to age 11-17 months
    Intervention: Dietary Supplement: LNS
  • Active Comparator: Corn-soy blend ++ (CSB++)
    CSB++ porridge, eaten over 6 months, age 6-12 months to age 11-17 months
    Intervention: Dietary Supplement: Corn-soy blend ++ (CSB++)
  • Active Comparator: Sprinkles
    Sprinkles added to borbor, eaten over 6 months, age 6-12 months to age 11-17 months
    Intervention: Dietary Supplement: Sprinkles
  • No Intervention: Control
    Plain borbor and thereafter family foods, eaten over 6 months, age 6-12 months to age 11-17 months
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 13, 2016)
487
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2014)
422
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cambodia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02257762
Other Study ID Numbers  ICMJE LNS-CAMB-INFANTS-EFF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bindi Borg, University of Sydney
Study Sponsor  ICMJE Institut de Recherche pour le Developpement, Cambodia
Collaborators  ICMJE
  • UNICEF
  • Department of Fisheries Post-harvest Technologies and Quality Control
Investigators  ICMJE
Study Director: Frank T Wieringa, MD, PhD IRD
Principal Investigator: Bindi Borg, MA,PhD cand. University of Sydney
PRS Account Institut de Recherche pour le Developpement, Cambodia
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP