NCT05614505

Brief Summary

Severe wasting or Severe Acute Malnutrition (SAM) continues to be a major public health problem in Indonesia, affecting more than 2 million children under 5 years old. A new approach to treat SAM is called Community-based management of acute malnutrition (CMAM), which has been designed to maximize the coverage and successful treatment of children with SAM, by providing Ready to Use Therapeutic Food (RUTF) through out-patient treatment. Since 2019, UNICEF has been working intensively to facilitate the local production of RUTF. This present study aims to assess the acceptability and efficacy of three locally produced RUTFs compared to the standard peanut based RUTF. The study will be implemented in Bogor district. A total of 300 children with uncomplicated SAM, aged 6-59 months old, meeting the inclusion criteria will be included in the study. This study is designed as a randomized controlled trial. The children will be allocated to one of the five intervention (1 control, 4 experimental) arms. Each child will receive one type of RUTF product for eight consecutive weeks. The ration given to a child will be based on the need for an intake of \~ 170 kcal/kg BW/day. Data will be collected at baseline, at weekly intervals and at exit. The primary outcome of interest for the efficacy study is the relative weight gain of children consuming each of the local RUTFs compared with those consuming the standard RUTF. The primary outcome of the acceptability of the RUTFs will be the amount of product consumed during the eight-week efficacy trial. Differences in weight and height gain will be analyzed using ANCOVA, controlling for age, gender, food intake, and morbidity. Repeated measurement statistics will be used to analyze differences in growth patterns over the eight-week intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

September 22, 2021

Last Update Submit

November 7, 2022

Conditions

Severe Acute Malnutrition

Keywords

Ready to use therapeutic food (RUTF)acceptabilitylocalchildrenrehabilitation

Outcome Measures

Primary Outcomes (3)

  • short-term acceptability

    Passing the appetite test

    consumption of at least 50% of RUTF provided in a 30 minute period

  • long-term acceptability

    drop-out during the intervention

    Number of children not finishing the 8 week intervention

  • weight gain over the 8 week intervention

    weight gain (in g) over 8 week intervention

    weight gain expressed as weight gain (g)/kg body weight per day over the 8 week intervention

Secondary Outcomes (5)

  • recovery rate

    from baseline to end of the 8 week intervention

  • increase in height for age Z scores (HAZ)

    from baseline to the end of the 8 week intervention

  • length of stay in the treatment

    8 week intervention or shorter

  • Morbidity during the intervention

    from baseline to 8 week intervention

  • Perception

    based on the interview with the caregiver after the 8 week intervention

Study Arms (5)

RUTF standard

ACTIVE COMPARATOR

PlumpyNut

Dietary Supplement: Ready to use therapeutic foods

RUTF local_1

EXPERIMENTAL

Soybean RUTF

Dietary Supplement: Ready to use therapeutic foods

RUTF local_2

EXPERIMENTAL

Mungbean-thick RUTF

Dietary Supplement: Ready to use therapeutic foods

RUTF local_3

EXPERIMENTAL

Mungbean-thin RUTF

Dietary Supplement: Ready to use therapeutic foods

RUTF local_4

EXPERIMENTAL

Wafer RUTF

Dietary Supplement: Ready to use therapeutic foods

Interventions

Ready to use therapeutic foodsDIETARY_SUPPLEMENT

locally produced therapeutic foods

RUTF local_1RUTF local_2RUTF local_3RUTF local_4RUTF standard

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with uncomplicated SAM (WHZ \< -3 and/or MUAC \<115 mm) qualified for outpatient treatment, or nutritional edema regardless of anthropometry
  • Aged 6-59 months old upon enrolment
  • Pass appetite test
  • Never received in- and outpatient treatment on SAM (including not having consumed RUTF, F75, F100 or special medical specialty food1 in the last two months
  • Willing to participate in the study (parent signed the informed consent)

You may not qualify if:

  • Body weight \< 4.0 kg;
  • Uncontrolled or untreatable systemic opportunistic infection, such as active TB, HIV;
  • Obvious dysmorphic features, general mental health problems (e.g., Down syndrome, etc.), other conditions interfering with normal growth;
  • 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 (including edema +3);
  • Severe anemia (Hb\<7g/dL);
  • Is a twin or multiple;
  • Allergy to milk, nuts, legumes and/or antibiotics (Amoxicillin and Ampicillin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Savica

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Frank Wieringa, MD PhD

    Institute de Recherche pour le Développement

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Given the very different characteristics of the RUTFs, full masking is not possible. Caregivers/mothers are only given 1 product, and do not know of the existence of the other intervention products
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

September 22, 2021

First Posted

November 14, 2022

Study Start

July 15, 2021

Primary Completion

December 15, 2021

Study Completion

January 25, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

ID(1)