High-protein Quantity and Quality RUTF in Improving Linear Growth Among Children With Severe Wasting

NCT05737472 | Completed DMC

• 1 other identifier: 1000079230
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This is a proof-of-concept trial that aims to compare the efficacy of an 8-week treatment with higher-protein-Ready-to-Use Therapeutic Foods (RUTF) with standard RUTF in improving levels of markers of growths, height, nutritional recovery, and lean mass deposition among children with severe wasting. The study will also assess the safety and acceptability of the high-protein RUTF in comparison to the standard RUTF. The study will be conducted at four outpatient therapeutic programs in the Blantyre district of Malawi.

Conditions

Severe Wasting; Severe Acute Malnutrition

Keywords

Child health; Ready-to-use therapeutic food; Severe acute malnutrition; RUTF; SAM; Wasting; Outpatient Therapeutic Programme; OTP

Outcome Measures

Primary Outcomes (1)

• Changes in plasma IGF-1

  To assess the efficacy of high-protein-RUTF with higher protein quality and quantity compared to standard RUTF in increasing circulating IGF- 1 in 6-23-month-old children with severe wasting.

  4 weeks

Secondary Outcomes (13)

• Changes in height for age z score

  8 weeks

• Changes in weight for age z score

  8 weeks

• Changes in weight for height z score

  8 weeks

• Changes in knee heel length

  8 weeks

• Changes in plasma essential amino acid profile leucine, threonine and tryptophan

  4 weeks

Study Arms (2)

Standard RUTF

ACTIVE COMPARATOR

The standard RUTF dose is according to weight as per the WHO 2013 guideline, thus 150-220Kcal/kg/day. A child will receive a weekly ration for 8 consecutive weeks from enrolment.

Dietary Supplement: Standard RUTF

High-protein RUTF

EXPERIMENTAL

The high-protein RUTF dose is according to weight as per the WHO 2013 guideline, thus 150-220Kcal/kg/day. A child will receive a weekly ration for 8 consecutive weeks from enrolment.

Dietary Supplement: High-protein RUTF

Interventions

High-protein RUTF DIETARY_SUPPLEMENT

The high-protein RUTF is isocaloric to the standard RUTF. To have a higher protein quantity and quality, the recipe has greater proportions of milk powder plus whey protein and vegetable oil. A total of 15% of energy is from protein. The protein quality score, digestible indispensable amino acid score (DIAAS )of the high protein, RUTF is 1.18 which is equivalent to a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 1.19

High-protein RUTF

Standard RUTF DIETARY_SUPPLEMENT

The standard RUTF was manufactured according to WHO recommendations, with at least 50% of protein-sourced dairy, mainly skim milk. A total of 10% of energy is from protein. The protein quality score, digestible indispensable amino acid score (DIAAS) of the standard RUTF is 0.76, which is equivalent to a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 0.86.

Standard RUTF

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants 6-23 months of age with severe wasting at OTP admission according to the WHO criteria: WHZ below -3 or MUAC below 115mm.
• Parent or guardian is able and available to consent
• Children who are able to feed orally in the usual state of health
• The primary caregiver plans to stay in the study area during the duration of the study.

You may not qualify if:

• Children with medical complications as per the CMAM guidelines (lack of appetite, severe oedematous malnutrition, acute infections)
• mild and moderate nutritional oedema
• Children with a known terminal illness (e.g. cancer), cerebral palsy (CP), tuberculosis (TB,) HIV infected or exposed
• Children who had SAM in the last 8 weeks, i.e., SAM relapses in the last 8 weeks
• Children admitted to any NRU due to complicated SAM in the previous 4 weeks will also be excluded
• Children whose caregivers refuse to give consent or whose primary givers are not available to give consent
• Children who were previously enrolled in this trial or currently enrolled in this trial whose sibling has also been enrolled in the study
• Children with known intolerance or allergy to high protein diets will be excluded as well as known intolerance or allergy to milk/lactose

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Ministry of Health, Malawi: collaborator
• Schlumberger Foundation: collaborator
• Nutriset: collaborator
• Friends of Sick Children, Malawi: collaborator

Study Sites (1)

Ndirande, Mbayani, Bangwe, Limbe and Bangwe health centres

Blantyre, 000, Malawi

Location

Related Publications (3)

• Potani I, Spiegel-Feld C, Brixi G, Bendabenda J, Siegfried N, Bandsma RHJ, Briend A, Daniel AI. Ready-to-Use Therapeutic Food (RUTF) Containing Low or No Dairy Compared to Standard RUTF for Children with Severe Acute Malnutrition: A Systematic Review and Meta-Analysis. Adv Nutr. 2021 Oct 1;12(5):1930-1943. doi: 10.1093/advances/nmab027.

  PMID: 33838044 BACKGROUND

• Shivakumar N, Jackson AA, Courtney-Martin G, Elango R, Ghosh S, Hodgkinson S, Xipsiti M, Lee WTK, Kurpad AV, Tome D. Protein Quality Assessment of Follow-up Formula for Young Children and Ready-to-Use Therapeutic Foods: Recommendations by the FAO Expert Working Group in 2017. J Nutr. 2020 Feb 1;150(2):195-201. doi: 10.1093/jn/nxz250.

  PMID: 31724705 BACKGROUND

• Potani I, Daniel AI, Briend A, Courtney-Martin G, Berkley JA, Voskuijl W, Vresk L, Bourdon C, Kathumba S, Mbale E, Bandsma RHJ. A protocol for a proof-of-concept randomized control trial testing increased protein quantity and quality in ready-to-use therapeutic food in improving linear growth among 6-23-month-old children with severe wasting in Malawi. PLoS One. 2023 Aug 24;18(8):e0287680. doi: 10.1371/journal.pone.0287680. eCollection 2023.

  PMID: 37619218 DERIVED

MeSH Terms

Conditions

Cachexia; Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Isabel Potani, PhD(c)

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients, investigators, care providers, and data analysts will be blinded from the treatment allocation until data analysis is complete, thus quadruple blinding. The two RUTFs will be packaged in identical 92g sachets. The RUTFs will be as similar as possible in colour, texture, and smell. The two packages/sachets of the two types of RUTF will differ by colour, and the number code will be either grey-88 or purple-99 (the colour code will be unique to each RUTF type). An independent statistician will perform the colour allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Staff Gastroenterologist, Principal Investigator

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: February 21, 2023
• Study Start: November 14, 2022
• Primary Completion: July 26, 2023
• Study Completion: August 23, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)