High-protein Quantity and Quality RUTF in Improving Linear Growth Among Children With Severe Wasting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2023-08-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a proof-of-concept trial that aims to compare the efficacy of an 8-week treatment with higher-protein-Ready-to-Use Therapeutic Foods (RUTF) with standard RUTF in improving levels of markers of growths, height, nutritional recovery, and lean mass deposition among children with severe wasting. The study will also assess the safety and acceptability of the high-protein RUTF in comparison to the standard RUTF. The study will be conducted at four outpatient therapeutic programs in the Blantyre district of Malawi.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Controlled Trial to Test the Efficacy of Lipid-based Nutrient Supplements to Prevent Severe Stunting Among Infants

NCT00524446

Malnutrition Stunting Developmental Delay

COMPLETED PHASE3

Severe Acute Malnutrition and Child Development Clinical Trial in Mwanza

NCT06781918

Severe Acute Malnutrition in Childhood

NOT_YET_RECRUITING PHASE3

Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection

NCT01154803

Malnutrition Malaria Lower Respiratory Tract Infection +1 more

COMPLETED NA

Trial on the Acceptability of Modified Lipid Based Nutrient Supplements Among Malawian Infants

NCT00885144

Malnutrition

COMPLETED PHASE1

Ready to Use Supplementary Food in Moderate Childhood Malnutrition

NCT01147198

Moderate Acute Malnutrition

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

RUTF has successfully promoted recovery from severe wasting and widened treatment coverage. However, RUTF does not sufficiently promote linear growth, leaving many survivors of severe wasting at risk of persistent stunting. Stunting is associated with long-term effects like poor child development and an increased risk of non-communicable diseases in adults. High protein quantity and quality are known to stimulate linear growth; however, an RUTF with a higher protein quantity and quality than the standard RUTF has yet to be tested. The investigators hypothesize that the suboptimal linear growth in children surviving severe malnutrition can be improved by increasing the protein quantity and quality in the standard RUTF formulation. The investigators have designed a high protein quantity and quality RUTF that will be tested in a proof-of-concept quadruple-blind randomised controlled trial study design. The trial aims to compare the efficacy of higher-protein-RUTF and standard RUTF in improving markers of linear growth among 6-23 months old children with severe wasting.

Children aged 6-23 months newly enrolled in outpatient treatment programs for severe wasting and without medical complications are eligible. They will be assigned to either increased protein RUTF or standard RUTF for eight weeks.

The primary outcome is a change in insulin-like growth factor-1 (IGF- 1) after four weeks of treatment. IGF-1 is a hormone that is mechanistically linked with growth. Secondary outcomes include ponderal and linear growth changes from baseline measured at eight weeks and plasma amino acid profile at four weeks. Other secondary outcomes are the acceptability and safety of high protein RUTF compared to standard RUTF. These findings will help to determine the optimal protein composition of RUTF to promote linear growth when treating severe wasting in children.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Wasting Severe Acute Malnutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The patients, investigators, care providers, and data analysts will be blinded from the treatment allocation until data analysis is complete, thus quadruple blinding. The two RUTFs will be packaged in identical 92g sachets. The RUTFs will be as similar as possible in colour, texture, and smell. The two packages/sachets of the two types of RUTF will differ by colour, and the number code will be either grey-88 or purple-99 (the colour code will be unique to each RUTF type). An independent statistician will perform the colour allocation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard RUTF

The standard RUTF dose is according to weight as per the WHO 2013 guideline, thus 150-220Kcal/kg/day. A child will receive a weekly ration for 8 consecutive weeks from enrolment.

Group Type ACTIVE_COMPARATOR

Standard RUTF

Intervention Type DIETARY_SUPPLEMENT

The standard RUTF was manufactured according to WHO recommendations, with at least 50% of protein-sourced dairy, mainly skim milk. A total of 10% of energy is from protein. The protein quality score, digestible indispensable amino acid score (DIAAS) of the standard RUTF is 0.76, which is equivalent to a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 0.86.

High-protein RUTF

The high-protein RUTF dose is according to weight as per the WHO 2013 guideline, thus 150-220Kcal/kg/day. A child will receive a weekly ration for 8 consecutive weeks from enrolment.

Group Type EXPERIMENTAL

High-protein RUTF

Intervention Type DIETARY_SUPPLEMENT

The high-protein RUTF is isocaloric to the standard RUTF. To have a higher protein quantity and quality, the recipe has greater proportions of milk powder plus whey protein and vegetable oil. A total of 15% of energy is from protein. The protein quality score, digestible indispensable amino acid score (DIAAS )of the high protein, RUTF is 1.18 which is equivalent to a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 1.19

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High-protein RUTF

The high-protein RUTF is isocaloric to the standard RUTF. To have a higher protein quantity and quality, the recipe has greater proportions of milk powder plus whey protein and vegetable oil. A total of 15% of energy is from protein. The protein quality score, digestible indispensable amino acid score (DIAAS )of the high protein, RUTF is 1.18 which is equivalent to a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 1.19

Intervention Type DIETARY_SUPPLEMENT

Standard RUTF

The standard RUTF was manufactured according to WHO recommendations, with at least 50% of protein-sourced dairy, mainly skim milk. A total of 10% of energy is from protein. The protein quality score, digestible indispensable amino acid score (DIAAS) of the standard RUTF is 0.76, which is equivalent to a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 0.86.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Infants 6-23 months of age with severe wasting at OTP admission according to the WHO criteria: WHZ below -3 or MUAC below 115mm.
* Parent or guardian is able and available to consent
* Children who are able to feed orally in the usual state of health
* The primary caregiver plans to stay in the study area during the duration of the study.

Exclusion Criteria

* Children with medical complications as per the CMAM guidelines (lack of appetite, severe oedematous malnutrition, acute infections)
* mild and moderate nutritional oedema
* Children with a known terminal illness (e.g. cancer), cerebral palsy (CP), tuberculosis (TB,) HIV infected or exposed
* Children who had SAM in the last 8 weeks, i.e., SAM relapses in the last 8 weeks
* Children admitted to any NRU due to complicated SAM in the previous 4 weeks will also be excluded
* Children whose caregivers refuse to give consent or whose primary givers are not available to give consent
* Children who were previously enrolled in this trial or currently enrolled in this trial whose sibling has also been enrolled in the study
* Children with known intolerance or allergy to high protein diets will be excluded as well as known intolerance or allergy to milk/lactose

Minimum Eligible Age

6 Months

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No