Among children aged 6–59 months with severe acute malnutrition in Sri Lanka, is a locally produced ready-to-use therapeutic food (RUTF), non-inferior compared with imported BP-100, in achieving recovery, anthropometric improvement, and clinical safety over an eight-week treatment period?

Study settings

The study will be conducted at six hospitals in Sri Lanka: a) Lady Ridgeway Hospital for Children, Colombo b) Colombo South Teaching Hospital c) Colombo North Teaching Hospital d) Teaching Hospital, Kalutara e) District General Hospital, Nuwara Eliya f) Dickoya Base Hospital

Eligible children will be recruited through paediatric and nutrition outpatient clinics at these hospitals. Weekly follow-up will be conducted at the relevant hospital clinic. When a participant cannot attend a scheduled clinic visit, the study team will conduct a home visit.

Randomization
This is a two-arm, parallel-group, double-blind, randomized, controlled non-inferiority trial. a) Method of randomization: Participants will be randomly allocated in a 1:1 ratio to the locally produced ready-to-use therapeutic food group or the imported BP-100 group. Allocation will be performed by drawing lots.
b) Unit of randomization: The individual child.
c) Method of sequence generation:
Randomization sequences will be generated separately for each of the six participating hospitals (stratified by site, to preserve the planned 37-per-arm allocation at each hospital) using the Research Randomizer web-based application, in blocks to maintain a 1:1 allocation ratio between the local RUTF and BP-100 arms.
d) Sequence generation:
The randomization sequence will be generated in advance by a designated investigator who is not involved in recruitment, eligibility assessment, or outcome assessment.
e) Allocation concealment : Allocation will be concealed using sequentially numbered, opaque, sealed envelopes, opened only after a child is confirmed eligible and consent has been obtained.

Intervention
Children allocated to the intervention arm will receive the locally produced ready-to-use therapeutic food orally for eight weeks.
The quantity provided will be calculated individually according to the child’s body weight. The total estimated nutritional requirement is 150–185 kilocalories per kilogram of body weight per day. Initially, approximately 50% of the child’s daily energy and nutritional requirements will be provided through the locally produced ready-to-use therapeutic food, while the remaining 50% will be provided through regular family meals. Therefore, the ready-to-use therapeutic food will initially provide approximately 75–92.5 kilocalories per kilogram per day.
The ready-to-use therapeutic food will be given orally as a snack in three to four divided feeds per day. The required quantity will be reviewed according to body weight and supplied weekly. If the caregiver is unable to provide adequate family meals, as determined through dietary assessment and monitoring of weight gain, the regimen may be changed to provide 100% of the child’s nutritional requirements through the ready-to-use therapeutic food. Any such change will be documented.

Control
Children allocated to the control arm will receive imported BP-100, the standard ready-to-use therapeutic food, orally for eight weeks.
The dose, route, frequency, and method of calculation will be the same as those used for the intervention arm. Initially, BP-100 will provide approximately 50% of the child’s daily energy and nutritional requirements, equivalent to approximately 75–92.5 kilocalories per kilogram per day, with the remaining requirement provided through regular family meals.
BP-100 will be given orally as a snack in three to four divided feeds per day. The required quantity will be calculated according to body weight and supplied weekly. If adequate family meals cannot be provided, the regimen may be changed to provide 100% of the child’s nutritional requirements through BP-100. Any such change will be documented.

Standard care available to both study arms Children in both arms will receive the same routine care, including:
- Medical assessment and clearance before enrolment
- An appetite test using the assigned product
- Caregiver counselling on feeding and product use
- Regular family meals under the initial 50% therapeutic-food regimen
- Clean drinking water with each feed
- Weekly clinical, nutritional, and anthropometric assessments
- Monitoring of dietary intake, product consumption, recent illnesses, adherence, and adverse events
- Referral for appropriate medical treatment when complications or adverse events occur
- Home visits and product delivery when a participant cannot attend a scheduled clinic visit

Blinding The imported BP-100 and the locally produced ready-to-use therapeutic food will be placed in identical coded packaging. For BP-100, the original inner wrapper will remain intact, while the outer wrapper will be removed. Two BP-100 tablets will be sealed in aluminium foil and vacuum-packed. The locally produced ready-to-use therapeutic food will be packed in the same manner to maintain similar external presentation.

The product coding and blinding process will be managed by designated members of the investigator team. The allocation code will remain confidential until completion of data collection and analysis, except when emergency unblinding is required for participant safety.

1. Children aged 6–59 months who have been diagnosed with SAM and are initiating treatment for the first time, defined by:
2. Weight-for-height z-score < -3 SD
3. No clinical complications requiring inpatient management (e.g., severe dehydration, hypoglycemia, hypothermia, sepsis, severe edema, or poor general condition) and
4. Have passed the RUTF appetite test at enrolment, demonstrating the ability to consume the minimum required amount and
5. The SAM children who are enrolled to the outpatient management by a Consultant Paediatrician or a Consultant Nutrition Physician

Children with SAM,
1. whose parents/ guardians don’t give consent for the study
2. who have known drug, food or any kind of an allergies or food intolerances
3. who live outside the Western Province (children who are treated at the selected hospitals in Western province) and outside the Nuwaraeliya District (children who are treated at the selected hospitals in Nuwaraeliya District) and who are planned to be followed up at different districts