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

Child Malnutrition Clinical Trial

Official title:

Efficacy of a Locally-Produced Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement (LNS) for Children Under Two Years in Cambodia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02257762
• Other study ID #: LNS-CAMB-INFANTS-EFF
• Status: Active, not recruiting
• Phase: N/A
• First received: October 2, 2014
• Last updated: September 13, 2016
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: September 2016
• Source: Institut de Recherche pour le Developpement, Cambodia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research CouncilCambodia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 487
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 12 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Malnutrition
• Child Nutrition Disorders
• Malnutrition

Intervention

Dietary Supplement:
• LNS
Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients
• Corn-soy blend ++ (CSB++)
Blended flour containing soy, corn, milk powder, oil, sugar and multiple micronutrients.
• Sprinkles
Multiple micronutrient powder packaged in sachet.

Locations

Country	Name	City	State
Cambodia	IRD Cambodia	Phnom Penh

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement, Cambodia	Fisheries Post Harvest Technologies and Quality, Cambodia, UNICEF

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Body composition	Triceps, biceps and/or subscapular skinfolds	6 months	No
Secondary	Iron status	Analysis of haemoglobin (g/l), ferritin (µg/l), tranferrin receptor (mg/l), C reactive protein (mg/l), and alpha-1-acid glycoprotein (mg/l)	6 months	No