Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?

The Washington University

Status: Completed

Conditions: Malnutrition, Child

Treatments: Dietary Supplement: RUSF skimmed milk powder; Dietary Supplement: RUSF soy and sucrose; Dietary Supplement: RUSF soy protein and whey permeate; Dietary Supplement: RUSF milk protein concentrate and sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT04216043

201912091

Details and patient eligibility

About

This study is to look at the types of sugar and protein composition in the treatment of moderate acute malnutrition and its effects on gut health. The study will use 4 different types of ready to use supplementary foods to see which one if any has better recovery rate along with looking into the gut health. Children will be treated using one food for up to 12 weeks. A subset of about 400 will be tested for intestinal permeability using the dual sugar test.

Enrollment: 1,102 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• MUAC < 12.5 cm and ≥ 11.5 cm without bipedal oedema

Exclusion criteria

• If they are involved in another research trial
• in another supplemental feeding program
• debilitating illness
• history of peanut or milk allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,102 participants in 4 patient groups

RUSF skimmed milk powder

Experimental group

Description:

RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.

Treatment:

Dietary Supplement: RUSF skimmed milk powder

RUSF milk protein concentrate and sucrose

Experimental group

Description:

RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.

Treatment:

Dietary Supplement: RUSF milk protein concentrate and sucrose

RUSF soy protein and whey permeate

Experimental group

Description:

RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.

Treatment:

Dietary Supplement: RUSF soy protein and whey permeate

RUSF soy and sucrose

Experimental group

Description:

RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.

Treatment:

Dietary Supplement: RUSF soy and sucrose