Severe Acute Malnutrition in ChildhoodNCT07345884
Treatment of Severe Acute Malnutrition in Children 6 to 59 Months Old With Standard Ready To Use Therapeutic Food Compared to a Newly Formulated Lipid Optimized Ready To Use Therapeutic Food
A study testing Lipid-Optimized Ready to Use Therapeutic Food (RUTF) and Ready to Use Therapeutic Food (RUTF) in people with Severe Acute Malnutrition in Childhood and Malnutrition, Child, run by University of California, Los Angeles at 1 site in Pakistan.
Trial summary
The goal of this randomized clinical trial is to learn if a newly formulated Lipid-Optimized Ready-to-Use Therapeutic Food (LO-RUTF) can treat severe acute malnutrition in children aged 6 to 59 months. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition in Childhood, Malnutrition, Child, Neurocognition, Child
- What is being tested?
- Lipid-Optimized Ready to Use Therapeutic Food (RUTF) and Ready to Use Therapeutic Food (RUTF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-59 months with severe acute malnutrition, i.e., MUAC <11.5 cm, and/or weight-for-height/length z-score < -3, and/or with bilateral pitting edema, with an appetite to completely consume a 30 g test feeding, and without medical complications presenting at selected rural therapeutic feeding health facilities
Who cannot join
- Children that are simultaneously involved in another research trial or supplemental feeding program, are developmentally delayed, have vision or hearing deficits, or have a history of milk or peanut allergy.
- Chronic diseases such as malabsorption, chronic kidney disease, inflammatory bowel disease, congenital heart disease, endocrine disorders (e.g., hypothyroidism, growth hormone deficiencies), recurrent infections (e.g., pneumonia, cough, fever, pharyngitis), chronic respiratory diseases (e.g., asthma, lung diseases), congenital or acquired immunodeficiency, and neurological disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Treatment of Severe Acute Malnutrition in Children 6 to 59 Months Old With Standard Ready To Use Therapeutic Food and Newly Formulated Lipid Optimized Ready To Use Therapeutic Food an Individual Randomized Double Blind Controlled Trial
The goal of this randomized clinical trial is to learn if a newly formulated Lipid-Optimized Ready-to-Use Therapeutic Food (LO-RUTF) can treat severe acute malnutrition in children aged 6 to 59 months. The main questions it aims to answer are:
- Does LO-RUTF impact physical recovery from severe acute malnutrition in participants?
- Does LO-RUTF impact neurocognitive performance after 8 and 12 weeks of treatment?
Read more
Researchers will compare LO-RUTF to standard RUTF see if our energy-dense food compares to standard issue RUTF in terms of promoting recovery from severe acute malnutrition.
Participants will
- Take a one-week ration of LO-RUTF or standard RUTF based on the participant's weight
- Return every week for checkups, tests and to receive the next ration of assigned RUTF if eligible
- Be assessed for neurocognitive function through Malawi Developmental Assessment Tool (MDAT) at three time points (before treatment, 4 weeks, 12 weeks)
- Being tested
- Lipid-Optimized Ready to Use Therapeutic Food (RUTF), Ready to Use Therapeutic Food (RUTF)
- Keywords
- RUTF, Ready-to-use therapeutic food
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid-Optimized Ready to Use Therapeutic Food (RUTF)Dietary supplement
Since this is a pilot trial for the study recipe, we have increased the vitamin D3 content in this RUTF as an experimental variable within this study.
Ready to Use Therapeutic Food (RUTF)Dietary supplement
Also called UNICEF RUTF, Standard RUTF
This is the standard of care RUTF with UNICEF product specifications. This RUTF will be produced internationally and shipped to Pakistan.
| Study group | Role | What they receive |
|---|---|---|
| LO-RUTF | Experimental | Participants in the LO-RUTF arm will receive approximately 190 kcal/kg/day of Lipid-Optimized Ready to Use Therapeutic Food (RUTF). This RUTF is locally produced and contains maize, milk powder, rice flour, soymeal, sugar, whey isolate, palm oil, flaxseed oil, coconut oil, premix and an emulsifier. Receives: Dietary Supplement: Lipid-Optimized Ready to Use Therapeutic Food (RUTF) |
| RUTF | Active comparator | Participants in the RUTF arm will receive approximately 190 kcal/kg/day of Ready to Use Therapeutic Food (RUTF). This RUTF produced by UNICEF contains peanut paste, sugar, non-fat dried milk, vegetable oil, a premix containing concentrated minerals and vitamins, and an emulsifier. Receives: Dietary Supplement: Ready to Use Therapeutic Food (RUTF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Recovered from Severe Acute Malnutrition as Assessed by WHO Anthro v3.1
The primary outcome is recovery from SAM, defined as: mid-upper arm circumference ≥ 11.5cm (for two consecutive weekly visits), and/or weight-for-height/length z-score > -3 SD, and/or no bilateral pitting edema (for two consecutive weekly visits).
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (8)
Change in MDAT Scores after 8 and 12 weeks of treatment
The global development score along with all subdomain scores of the MDAT will be used as a measure of neurocognitive performance. with a higher score indicating a better outcome.
Measured: Baseline and after 8 and 12 weeks of treatment
Time to Recovery from Severe Acute Malnutrition
Defined as time taken to recover from severe acute malnutrition, which is defined as: mid-upper-arm-circumference ≥ 11.5cm (for two consecutive weekly visits), and/or weight-for-height z-score > -3, and/or no bilateral pitting edema (for two consecutive weekly visits).
Measured: From enrollment to the end of the study period at 12 weeks
Time to Recovery from Moderate Acute Malnutrition
Defined as time taken to achieve a mid-upper-arm-circumference ≥12.5 cm
Measured: From enrollment to the end of the study period at 12 weeks
Proportion of Participants with Relapse of Moderate Acute Malnutrition
Participants developing moderate acute malnutrition at any point after achieving recovery from severe acute malnutrition compared to all participants
Measured: From enrollment to the end of the study period at 12 weeks
Proportion of Participants with Relapse of Severe Acute Malnutrition
Participants developing severe acute malnutrition at any point after achieving recovery from severe acute malnutrition compared to all participants
Measured: From enrollment to the end of the study period at 12 weeks
Number of Participants with Non-Responder Status
Participants who have not met the SAM exit criteria after 3 months (MUAC > 11.5 cm, clinically well, > 15 % weight gain, and no oedema for two consecutive visits) will receive a non-responder outcome.
Measured: From enrollment to the end of the study period at 12 weeks
Incidence of Adverse Events
Number of participants with any adverse events, including those judged to be related to the study RUTF
Measured: From enrollment to the end of the study period at 12 weeks
Incidence of Hypercalcemia, Hypervitaminosis D, or excessive DHA concentrations
Determined by biochemical assessments at 8 weeks to evaluate serum 25-hydroxyvitamin D, calcium, and DHA concentrations.
Measured: From baseline to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study startJun 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Malnutrition in ChildhoodStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in both interventions will receive approximately 190 kcal/kg/day of LO-RUTF or standard RUTF. The standard RUTF will be produced internationally and shipped to Pakistan. The alternative treatment for SAM, LO-RUTF, is produced locally in Pakistan.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University
- Responsible party
- Principal investigator, Ahmed Moutwakil, University of California, Los Angeles
- Investigators
- Kiran K Masood, MD, Principal investigator, University of California, Los AngelesMohid Khan, Study director, The Satya Nutrition FoundationSamir Ismail, Study chair, The Satya Nutrition FoundationAkhila Annadanam, Study chair, The Satya Nutrition FoundationTu Nguyen, Study chair, The Satya Nutrition FoundationFatima Ahmad, Study chair, The Satya Nutrition FoundationMeghana Dantuluri, Study chair, The Satya Nutrition FoundationAmith Umesh, Study director, The Satya Nutrition Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345884
- Sponsor's protocol ID
- IRB-25-1096
- Status last verified
- Mar 2026
- First submitted
- 2 Jan 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment of Severe Acute Malnutrition in Children 6 to 59 Months Old With Standard Ready To Use Therapeutic Food and Newly Formulated Lipid Optimized Ready To Use Therapeutic Food an Individual Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07345884
- Acronym / sponsor ID
- IRB-25-1096
- Keywords
- RUTF, Ready-to-use therapeutic food
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Aga Khan University
- Study start
- Jun 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized clinical trial is to learn if a newly formulated Lipid-Optimized Ready-to-Use Therapeutic Food (LO-RUTF) can treat severe acute malnutrition in children aged 6 to 59 months. The main questions it aims to answer are:
- Does LO-RUTF impact physical recovery from severe acute malnutrition in participants?
- Does LO-RUTF impact neurocognitive performance after 8 and 12 weeks of treatment?
Researchers will compare LO-RUTF to standard RUTF see if our energy-dense food compares to standard issue RUTF in terms of promoting recovery from severe acute malnutrition.
Participants will
- Take a one-week ration of LO-RUTF or standard RUTF based on the participant's weight
- Return every week for checkups, tests and to receive the next ration of assigned RUTF if eligible
- Be assessed for neurocognitive function through Malawi Developmental Assessment Tool (MDAT) at three time points (before treatment, 4 weeks, 12 weeks)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants in both interventions will receive approximately 190 kcal/kg/day of LO-RUTF or standard RUTF. The standard RUTF will be produced internationally and shipped to Pakistan. The alternative treatment for SAM, LO-RUTF, is produced locally in Pakistan.
| Arm | Type | Receives |
|---|---|---|
| LO-RUTF | Experimental | Dietary Supplement: Lipid-Optimized Ready to Use Therapeutic Food (RUTF)Participants in the LO-RUTF arm will receive approximately 190 kcal/kg/day of Lipid-Optimized Ready to Use Therapeutic Food (RUTF). This RUTF is locally produced and contains maize, milk powder, rice flour, soymeal, sugar, whey isolate, palm oil, flaxseed oil, coconut oil, premix and an emulsifier. |
| RUTF | Active comparator | Dietary Supplement: Ready to Use Therapeutic Food (RUTF)Participants in the RUTF arm will receive approximately 190 kcal/kg/day of Ready to Use Therapeutic Food (RUTF). This RUTF produced by UNICEF contains peanut paste, sugar, non-fat dried milk, vegetable oil, a premix containing concentrated minerals and vitamins, and an emulsifier. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 6-59 months with severe acute malnutrition, i.e., MUAC <11.5 cm, and/or weight-for-height/length z-score < -3, and/or with bilateral pitting edema, with an appetite to completely consume a 30 g test feeding, and without medical complications presenting at selected rural therapeutic feeding health facilities
Key exclusion criteria (2 listed)
- Children that are simultaneously involved in another research trial or supplemental feeding program, are developmentally delayed, have vision or hearing deficits, or have a history of milk or peanut allergy.
- Chronic diseases such as malabsorption, chronic kidney disease, inflammatory bowel disease, congenital heart disease, endocrine disorders (e.g., hypothyroidism, growth hormone deficiencies), recurrent infections (e.g., pneumonia, cough, fever, pharyngitis), chronic respiratory diseases (e.g., asthma, lung diseases), congenital or acquired immunodeficiency, and neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipid-Optimized Ready to Use Therapeutic Food (RUTF)Since this is a pilot trial for the study recipe, we have increased the vitamin D3 content in this RUTF as an experimental variable within this study. | Dietary supplement | LO-RUTF |
| Ready to Use Therapeutic Food (RUTF)Also: UNICEF RUTF, Standard RUTFThis is the standard of care RUTF with UNICEF product specifications. This RUTF will be produced internationally and shipped to Pakistan. | Dietary supplement | RUTF |
Primary outcome
Number of Participants Recovered from Severe Acute Malnutrition as Assessed by WHO Anthro v3.1
Time frame: From enrollment to the end of treatment at 8 weeks
The primary outcome is recovery from SAM, defined as: mid-upper arm circumference ≥ 11.5cm (for two consecutive weekly visits), and/or weight-for-height/length z-score > -3 SD, and/or no bilateral pitting edema (for two consecutive weekly visits).
8 secondary outcomes
Change in MDAT Scores after 8 and 12 weeks of treatment
Time frame: Baseline and after 8 and 12 weeks of treatment
Time to Recovery from Severe Acute Malnutrition
Time frame: From enrollment to the end of the study period at 12 weeks
Time to Recovery from Moderate Acute Malnutrition
Time frame: From enrollment to the end of the study period at 12 weeks
Proportion of Participants with Relapse of Moderate Acute Malnutrition
Time frame: From enrollment to the end of the study period at 12 weeks
Proportion of Participants with Relapse of Severe Acute Malnutrition
Time frame: From enrollment to the end of the study period at 12 weeks
Number of Participants with Non-Responder Status
Time frame: From enrollment to the end of the study period at 12 weeks
Incidence of Adverse Events
Time frame: From enrollment to the end of the study period at 12 weeks
Incidence of Hypercalcemia, Hypervitaminosis D, or excessive DHA concentrations
Time frame: From baseline to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kiran K Masood, MD principal investigator
University of California, Los Angeles
Mohid Khan study director
The Satya Nutrition Foundation
Samir Ismail study chair
The Satya Nutrition Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipid-Optimized Ready to Use Therapeutic Food (RUTF) and Ready to Use Therapeutic Food (RUTF) in people with Severe Acute Malnutrition in Childhood and Malnutrition, Child, run by University of California, Los Angeles at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Moutwakil (4244853200, amoutwakil@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Recovered from Severe Acute Malnutrition as Assessed by WHO Anthro v3.1 (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.