NCT02257762

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
487

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

October 2, 2014

Last Update Submit

September 13, 2016

Conditions

Child Malnutrition

Keywords

Ready-to-use supplementary food (RUSF)Lipid-based nutrient supplement (LNS)Multiple micronutrients (MMN)Complementary feedingHome fortificationEfficacy/impactInfant and young child feeding (IYCF)CambodiaCluster randomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Nutritional status

    Weight-for-height (WHZ), length/height-for-age (L/HAZ), and weight-for-age (WAZ) calculated through monthly weight and height measurements

    6 months

Secondary Outcomes (2)

  • Body composition

    6 months

  • Iron status

    6 months

Study Arms (4)

Lipid-based nutrient supplement (LNS)

EXPERIMENTAL

LNS added to borbor, eaten over 6 months, age 6-12 months to age 11-17 months

Dietary Supplement: LNS

Corn-soy blend ++ (CSB++)

ACTIVE COMPARATOR

CSB++ porridge, eaten over 6 months, age 6-12 months to age 11-17 months

Dietary Supplement: Corn-soy blend ++ (CSB++)

Sprinkles

ACTIVE COMPARATOR

Sprinkles added to borbor, eaten over 6 months, age 6-12 months to age 11-17 months

Dietary Supplement: Sprinkles

Control

NO INTERVENTION

Plain borbor and thereafter family foods, eaten over 6 months, age 6-12 months to age 11-17 months

Interventions

LNSDIETARY_SUPPLEMENT

Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients

Lipid-based nutrient supplement (LNS)
Corn-soy blend ++ (CSB++)DIETARY_SUPPLEMENT

Blended flour containing soy, corn, milk powder, oil, sugar and multiple micronutrients.

Also known as: Supercereal Plus
Corn-soy blend ++ (CSB++)
SprinklesDIETARY_SUPPLEMENT

Multiple micronutrient powder packaged in sachet.

Sprinkles

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRD Cambodia

Phnom Penh, Cambodia

Location

Related Publications (2)

  • Borg B, Sok D, Mihrshahi S, Griffin M, Chamnan C, Berger J, Laillou A, Roos N, Wieringa FT. Effectiveness of a locally produced ready-to-use supplementary food in preventing growth faltering for children under 2 years in Cambodia: a cluster randomised controlled trial. Matern Child Nutr. 2020 Jan;16(1):e12896. doi: 10.1111/mcn.12896.

    PMID: 31885221DERIVED

  • Borg B, Mihrshahi S, Griffin M, Sok D, Chhoun C, Laillou A, Berger J, Wieringa FT. Randomised controlled trial to test the effectiveness of a locally-produced ready-to-use supplementary food (RUSF) in preventing growth faltering and improving micronutrient status for children under two years in Cambodia: a study protocol. Nutr J. 2018 Mar 16;17(1):39. doi: 10.1186/s12937-018-0346-x.

    PMID: 29548287DERIVED

MeSH Terms

Conditions

Child Nutrition DisordersTooth, Impacted

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Frank T Wieringa, MD, PhD

    IRD

    STUDY DIRECTOR

  • Bindi Borg, MA,PhD cand.

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
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

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

CA(1)