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

NCT ID: NCT05319717

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-08-31

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.

Detailed Description

Rice bran is a nutrient dense food ingredient with prebiotics and phytochemicals, as well as vitamins, fatty acids, and amino acids. The investigators will determine if the inclusion of rice bran to locally produced RUTFs will improve SAM treatment for children in Indonesia. This will be assessed by standard anthropometric measures and determining the modulation of the malnourished child's gut microbiome and metabolome. The study will also assess rates of relapse in the entire cohort.

This study will yield new information of direct importance and impact to public health nutrition and advance our knowledge and treatment of SAM in Indonesia. Investigation of the gut-microbiota metabolism following consumption of rice bran provided in RUTFs compared to RUTF without rice bran included will provide key mechanistic insights for repairing nutrient absorptive functions in the gut, sustaining gut health in treated children and inform long-term treatment solutions for SAM.

Conditions

Severe Acute Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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, with heat stabilized rice bran (Experimental)

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DIETARY_SUPPLEMENT

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

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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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).
• SAM with complications requiring hospital treatment. (Upon discharge from hospital, the child will be re-evaluated for inclusion in the study).
• 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

Savica, Indonesia

UNKNOWN

Sponsor Role: collaborator

Institute of Research for Development, France

OTHER_GOV

Sponsor Role: collaborator

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth P Ryan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Damayanti Soekarjo, PhD

Role: PRINCIPAL_INVESTIGATOR

Savica, Indonesia

Locations

Savica

Jember, East Java, Indonesia

Countries

Indonesia

References

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.

Reference Type: BACKGROUND

PMID: 38000818 (View on PubMed)

Other Identifiers

CSU IRB#:1823

Identifier Type: -

Identifier Source: org_study_id