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

Primary Purpose

Severe Acute Malnutrition

Status

Active

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Severe Acute Malnutrition

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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 as having uncomplicated SAM according to WHO criteria (WHZ < -3 and/or mid-upper arm circumference (MUAC) <115 mm) or a child with mild to moderate nutritional edema (regardless of anthropometry). These inclusion criteria align also with the criteria stated in the Indonesian National Guidelines for the management of acute malnutrition for the detection of severe acute malnutrition without complication.
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

Sites / Locations

Savica

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

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

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

Stool microbiota composition

Determine stool microbiota composition of infants in both arms over time using 16S rRNA sequencing and shotgun metagenomic sequencing.

Dried blood spot metabolite profile

Dried blood spots will be analyzed for metabolites.

Relapse

Determine the number of participants that experience severe acute malnutrition relapse 4 weeks after the treatment/intervention has ended.

Percent of children recovered

The number of children recovered in the 4 week treatment period will be determined as well as the time to recovery (days).

Full Information

NCT ID

NCT05319717

First Posted

February 5, 2022

Last Updated

June 1, 2023

Sponsor

Colorado State University

Collaborators

Thrasher Research Fund, Savica, Indonesia, Institute of Research for Development, France

1. Study Identification

Unique Protocol Identification Number

NCT05319717

Brief Title

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

Official Title

Rice Bran in Ready-to-use Therapeutic Foods for Microbiota-targeted Treatment of Childhood Malnutrition

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 1, 2022 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Colorado State University

Collaborators

Thrasher Research Fund, Savica, Indonesia, Institute of Research for Development, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Acute Malnutrition

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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)

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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).

Primary Outcome Measure Information:

Title

Description

This will be assessed by measures of: - Weight

Time Frame

Baseline, week 4, week 8, and week 16

Title

Description

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

Time Frame

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

Title

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Stool microbiota composition

Description

Determine stool microbiota composition of infants in both arms over time using 16S rRNA sequencing and shotgun metagenomic sequencing.

Time Frame

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

Title

Dried blood spot metabolite profile

Description

Dried blood spots will be analyzed for metabolites.

Time Frame

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

Title

Relapse

Description

Determine the number of participants that experience severe acute malnutrition relapse 4 weeks after the treatment/intervention has ended.

Time Frame

Week 16 (end of study)

Title

Percent of children recovered

Description

The number of children recovered in the 4 week treatment period will be determined as well as the time to recovery (days).

Time Frame

Baseline, week 4, week 8, and week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

59 Months

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Damayanti Soekarjo, PhD

Organizational Affiliation

Savica, Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Savica

City

Jember

State/Province

East Java

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IRB approved study protocol and informed consent forms will be shared.

IPD Sharing Time Frame

Protocol and informed consent will be shared after enrollment of the first 100 participants

IPD Sharing Access Criteria

Sharing access will be made available from the investigative team directly

Learn more about this trial

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

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