Severe Acute MalnutritionREFINE-SAMNCT07130877
RECIPE BASED F100 INTERVENTION FOR NUTRITIONAL EFFICACY IN SAM (REFINE-SAM )
A study testing WHO F100 and WHO RECIPE BASED F100 in people with Severe Acute Malnutrition, run by Children's Hospital and Institute of Child Health, Multan at 2 sites in Pakistan.
Trial summary
This open-label randomized controlled trial evaluates the efficacy and safety of multiple formulations of the F-100 therapeutic feed during the rehabilitation phase among children aged 6-59 months with SAM, in comparison to standard WHO F-100. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition
- What is being tested?
- WHO F100 and WHO RECIPE BASED F100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jan 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosed with SAM
- Have completed stabilization and entering rehabilitation phase per WHO CMAM guidelines
Who cannot join
- Secondary malnutrition (e.g. tuberculosis, HIV)
- Chronic systemic diseases
- Congenital anomalies
- Terminal illness
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Children's Hospital and Institute of child health Multan
Multan, Punjab Province, 60000
Tehsil Head Quater Sujah Abad
Multan Khurd, Punjab Province, 60000
About this study
Official title: EFFICACY AND SAFETY OF F100 PREPARED BY RECIPE METHOD FOR WEIGHT GAIN IN SEVERELY ACUTE MALNOURISHED CHILDREN
This open-label randomized controlled trial evaluates the efficacy and safety of multiple formulations of the F-100 therapeutic feed during the rehabilitation phase among children aged 6-59 months with SAM, in comparison to standard WHO F-100. The primary outcome is daily weight gain (g/kg/day) over 10 days; secondary outcomes include MUAC improvement, gastrointestinal tolerance (vomiting/diarrhea), duration to recovery, and renal safety markers (serum urea, creatinine, serum sodium, urine-specific gravity).
Read the detailed description
This open-label randomized controlled trial evaluates the efficacy and safety of multiple formulations of the F-100 therapeutic feed during the rehabilitation phase among children aged 6-59 months with SAM, in comparison to standard WHO F-100. The study includes four arms: the WHO commercial F-100 powder (control), recipe-based locally prepared F-100 (Arm A), diluted F-100 (Arm B), and an alternative locally prepared high-energy RUTF-like blend (Arm C). The primary outcome is daily weight gain (g/kg/day) over 10 days; secondary outcomes include MUAC improvement, gastrointestinal tolerance (vomiting/diarrhea), duration to recovery, and renal safety markers (serum urea, creatinine, serum sodium, urine-specific gravity).
- Conditions
- Severe Acute Malnutrition
- Being tested
- WHO F100, WHO RECIPE BASED F100
- Keywords
- F100, Recipe-based formula, Therapeutic feeding
- Medical subject headings
- Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO F100Dietary supplement
WHO F1OO
WHO RECIPE BASED F100Dietary supplement
Recipe-made formula will be given after initial stabilization, starting from 150 kcal per kg per day to a maximum of 220 kcal per kg per day at 4-hourly intervals, and intakes and vitals will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| WHO F-100 Formula | Active comparator | WHO already made formula will be given after initial stabilization starting from 150 kcal per kg per day to a maximum of 220 kcal per kg per day at 4-hourly intervals, and intakes and vitals will be monitored. Receives: Dietary Supplement: WHO F100 |
| WHO RECIPE MADE F100 | Experimental | Who recipe made F100 formula will be given after initial stabilization, starting from 150 kcal per kg per day to a maximum of 220 kcal per kg per day at 4-hourly intervals, and intakes and vitals will be monitored. Receives: Dietary Supplement: WHO RECIPE BASED F100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean weight gain (g/kg/day) during rehabilitation
Mean weight gain (g/kg/day) during 10 days of rehabilitation
Measured: From randomization to after starting treatment 10 days
Secondary outcomes (4)
MUAC
Improvement of F MUAC
Measured: From randomization to after starting treatment 10 days
Safety profile
Incidence of treatment-related adverse events (nausea, vomiting, and fluid overload) assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: From randomization to after starting treatment 10 days
Acceptability and Palatability by Hedonic scale scores for taste and acceptability of F-100
Palatability assessed using a 5-point Hedonic Scale adapted for pediatric populations. Scores collected on day 1
Measured: day 1
Change in serum albumin levels from baseline to day 10
Serum albumin measured in g/dL using a standard automated biochemical analyzer. Change calculated as day 10 value minus baseline value.
Measured: base line and day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Jan 2025
- Primary completion1 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital and Institute of Child Health, Multan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Saadia Khan, Children's Hospital and Institute of Child Health, Multan
- Investigators
- Muhammad T Sultan, PhD, Study chair, Bahuddin Zakariya University,Multan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130877
- Sponsor's protocol ID
- U1111-1326-4619
- Acronym
- REFINE-SAM
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY AND SAFETY OF F100 PREPARED BY RECIPE METHOD FOR WEIGHT GAIN IN SEVERELY ACUTE MALNOURISHED CHILDREN
- ClinicalTrials.gov ID
- NCT07130877
- Acronym / sponsor ID
- REFINE-SAM / U1111-1326-4619
- Conditions
- Severe Acute Malnutrition
- Keywords
- F100, Recipe-based formula, Therapeutic feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Children's Hospital and Institute of Child Health, MultanOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 Aug 2025 (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.
This open-label randomized controlled trial evaluates the efficacy and safety of multiple formulations of the F-100 therapeutic feed during the rehabilitation phase among children aged 6-59 months with SAM, in comparison to standard WHO F-100. The primary outcome is daily weight gain (g/kg/day) over 10 days; secondary outcomes include MUAC improvement, gastrointestinal tolerance (vomiting/diarrhea), duration to recovery, and renal safety markers (serum urea, creatinine, serum sodium, urine-specific gravity).
Detailed description
This open-label randomized controlled trial evaluates the efficacy and safety of multiple formulations of the F-100 therapeutic feed during the rehabilitation phase among children aged 6-59 months with SAM, in comparison to standard WHO F-100. The study includes four arms: the WHO commercial F-100 powder (control), recipe-based locally prepared F-100 (Arm A), diluted F-100 (Arm B), and an alternative locally prepared high-energy RUTF-like blend (Arm C). The primary outcome is daily weight gain (g/kg/day) over 10 days; secondary outcomes include MUAC improvement, gastrointestinal tolerance (vomiting/diarrhea), duration to recovery, and renal safety markers (serum urea, creatinine, serum sodium, urine-specific gravity).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WHO F-100 Formula | Active comparator | Dietary Supplement: WHO F100WHO already made formula will be given after initial stabilization starting from 150 kcal per kg per day to a maximum of 220 kcal per kg per day at 4-hourly intervals, and intakes and vitals will be monitored. |
| WHO RECIPE MADE F100 | Experimental | Dietary Supplement: WHO RECIPE BASED F100Who recipe made F100 formula will be given after initial stabilization, starting from 150 kcal per kg per day to a maximum of 220 kcal per kg per day at 4-hourly intervals, and intakes and vitals will be monitored. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6-59 months
- Diagnosed with SAM
- Have completed stabilization and entering rehabilitation phase per WHO CMAM guidelines
Key exclusion criteria (4 listed)
- Secondary malnutrition (e.g. tuberculosis, HIV)
- Chronic systemic diseases
- Congenital anomalies
- Terminal illness
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 |
|---|---|---|
| WHO F100WHO F1OO | Dietary supplement | WHO F-100 Formula |
| WHO RECIPE BASED F100Recipe-made formula will be given after initial stabilization, starting from 150 kcal per kg per day to a maximum of 220 kcal per kg per day at 4-hourly intervals, and intakes and vitals will be monitored. | Dietary supplement | WHO RECIPE MADE F100 |
Primary outcome
Mean weight gain (g/kg/day) during rehabilitation
Time frame: From randomization to after starting treatment 10 days
Mean weight gain (g/kg/day) during 10 days of rehabilitation
4 secondary outcomes
MUAC
Time frame: From randomization to after starting treatment 10 days
Safety profile
Time frame: From randomization to after starting treatment 10 days
Acceptability and Palatability by Hedonic scale scores for taste and acceptability of F-100
Time frame: day 1
Change in serum albumin levels from baseline to day 10
Time frame: base line and day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Munirul Islam MM, Dafni M, et al. Efficacy of F-100, diluted F-100 (F100D), and infant formula as rehabilitation diet for infants aged \< 6 months with severe acute malnutrition: a randomized clinical trial. Eur J Nutr. 2020Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Severe Acute Malnutrition
Recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Not yet recruiting
The Relapse to Acute Malnutrition Prevention (RAMP) Trial
Acute Malnutrition in Childhood, Acute Malnutrition, Severe
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Recruiting
Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia
Acute Malnutrition, Severe, Malnutrition, Child
Active, not recruiting
Choline to Improve Malnutrition and Enhance Cognition
Severe Acute Malnutrition, Cognitive Impairment
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. This study is not recruiting at the moment.
Muhammad T Sultan, PhD study chair
Bahuddin Zakariya University,Multan.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO F100 and WHO RECIPE BASED F100 in people with Severe Acute Malnutrition, run by Children's Hospital and Institute of Child Health, Multan at 2 sites 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean weight gain (g/kg/day) during rehabilitation (time frame: From randomization to after starting treatment 10 days). 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 24 Aug 2025.