Rice Bran-based Supplemental Foods for the Treatment of Childhood Malnutrition

NCT05319717 | Completed Phase 2

• 1 other identifier: CSU IRB#:1823
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy of treating children with severe acute malnutrition (SAM) with a locally produced ready-to-use therapeutic food (RUTF) with or without rice bran.

Conditions

Severe Acute Malnutrition

Outcome Measures

Primary Outcomes (3)

• Efficacy of the locally produced ready-to-use therapeutic food + heat stabilized rice bran as compared to locally produced ready-to-use therapeutic food alone in the treatment of severe acute malnutrition as determined by child weight.

  This will be assessed by measures of: \- Weight

  Baseline, week 4, week 8, and week 16

• Efficacy of the locally produced ready-to-use therapeutic food + heat stabilized rice bran as compared to locally produced ready-to-use therapeutic food alone in the treatment of severe acute malnutrition as determined by mid-upper arm circumference.

  This will be assessed by measures of: -Mid-upper arm circumference

  Changes between baseline, week 4, week 8, and week 16

• Efficacy of the locally produced ready-to-use therapeutic food + heat stabilized rice bran as compared to locally produced ready-to-use therapeutic food alone in the treatment of severe acute malnutrition as determined by morbidity.

  This will be assessed by measures of: \- Morbidity (diarrhea, fever, vomiting, upper or lower respiratory infection)

  Changes between baseline, week 4, week 8, and week 16

Secondary Outcomes (4)

• Stool microbiota composition

  Changes between baseline, week 4, week 8, and week 16

• Dried blood spot metabolite profile

  Changes between baseline, week 4, week 8, and week 16

• Relapse

  Week 16 (end of study)

• Percent of children recovered

  Baseline, week 4, week 8, and week 16

Study Arms (2)

Ready-to-use therapeutic food, no rice bran (control/comparator)

ACTIVE COMPARATOR

Randomized participants will receive a locally produced ready-to-use therapeutic food to be consumed daily.

Dietary Supplement: Ready-to-use therapeutic food (no rice bran)

Ready-to-use therapeutic food, with heat stabilized rice bran (Experimental)

EXPERIMENTAL

Randomized participants will receive a locally produced ready-to-use therapeutic food with 5% heat stabilized rice bran to be consumed daily.

Dietary Supplement: Ready-to-use therapeutic food with heat stabilized rice bran

Interventions

Ready-to-use therapeutic food with heat stabilized rice bran DIETARY_SUPPLEMENT

Children assigned to the experimental group will be treated for severe acute malnutrition with a novel ready-to-use therapeutic food that contains 5% heat stabilized rice bran.

Ready-to-use therapeutic food, with heat stabilized rice bran (Experimental)

Ready-to-use therapeutic food (no rice bran) DIETARY_SUPPLEMENT

Children assigned to the active comparator group will be treated for severe acute malnutrition with a novel ready-to-use therapeutic food (no rice bran).

Ready-to-use therapeutic food, no rice bran (control/comparator)

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Willing to participate in the study, with parent(s) signing the informed consent. If the caretaker denies the participation of the child, the child will be enrolled for treatment through the health system, but the information will be not considered for the purpose of the trial.
• Child identified with a weight-for-height z-score WHZ of \< -2.5 (SAM children and children with advanced moderate acute malnutrition) and/or mid-upper arm circumference (MUAC) \<115 mm) or a child with mild to moderate nutritional edema (regardless of anthropometry).
• Being qualified for outpatient treatment.
• Aged 6-59 months old upon enrolment
• Pass appetite test (taste test) (as stipulated by WHO guidelines on the treatment of SAM). See appetite test document attached.
• Not having consumed RUTF in the last two months

You may not qualify if:

• Children detected with severe acute malnutrition younger than 6 months of age will be excluded from the project, as well as any child with a body weight \<4.0 kg.
• Children 6-59 months old who, when diagnosed with SAM, have been detected with medical complications, with TB, HIV positive status, one or more signs from the Integrated Management of Childhood Illness (IMCI) guidelines, severe oedema (+++) or who have failed the appetite test (see appetite test document attached).
• Medical complications include: Cough/difficulty in breathing; Diarrhea; Fever; Ear Problems. IMCI signs will be identified according to WHO definition and include not able to drink or breastfeed; vomiting; convulsions; lethargy.
• Participating in another clinical trial
• Any congenital disorder that interferes with normal nutrient intake; chronic conditions including but not exclusively disorders of heart, kidney or liver (children to be screened by a physician).
• Siblings will not be allowed to participate in the trial
• Withdrawal criteria:
• Not consuming the RUTF supplementation at all in \>4 days a week in 2 consecutive weeks.
• Not providing samples or completing forms/questionnaires at study visits
• Developing medical complications requiring hospitalization
• Not gaining weight after 1 month of treatment
• Major reactions to intervention

Sponsors & Collaborators

• Colorado State University: lead
• Thrasher Research Fund: collaborator
• Savica, Indonesia: collaborator
• Institute of Research for Development, France: collaborator

Study Sites (1)

Savica

Jember, East Java, Indonesia

Location

Related Publications (1)

• Weber AM, Barbazza S, Fauzi MD, Rachmadewi A, Zuhrina R, Putri FK, Campos Ponce M, Hoeven MV, Rimbawan R, Nasution Z, Giriwono PE, Wieringa FT, Soekarjo DD, Ryan EP. Solutions to Enhance Health with Alternative Treatments (SEHAT) protocol: a double-blinded randomised controlled trial for gut microbiota-targeted treatment of severe acute malnutrition using rice bran in ready-to-use therapeutic foods in Indonesia. BMJ Open. 2023 Nov 24;13(11):e076805. doi: 10.1136/bmjopen-2023-076805.

  PMID: 38000818 BACKGROUND

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Damayanti Soekarjo, PhD

  Savica, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Control study arm: Locally produced Ready to use therapeutic food (RUTF) Intervention study arm: Locally produced Ready to use therapeutic food plus rice bran (RUTF+RB)

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: April 8, 2022
• Study Start: December 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Protocol and informed consent will be shared after enrollment of the first 100 participants
• Access Criteria: Sharing access will be made available from the investigative team directly

Locations

ID (1)