Clinical trial NCT02257762: Efficacy of a Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement for Children Under Two in Cambodia
Official title: Efficacy of a Locally-Produced Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement (LNS) for Children Under Two Years in Cambodia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Malnutrition
Keywords: 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
Lead sponsor: Institut de Recherche pour le Developpement, Cambodia
Sponsor class: OTHER_GOV
Collaborators: name: UNICEF
name: Department of Fisheries Post-harvest Technologies and Quality Control
First posted: 2014-10-06
Enrollment: 487
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Nutritional status
timeFrame: 6 months
Secondary outcomes:
measure: Body composition
timeFrame: 6 months
measure: Iron status
timeFrame: 6 months
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: IRD Cambodia
Study officials:
affiliation: IRD
name: Frank T Wieringa, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Sydney
name: Bindi Borg, MA,PhD cand.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.