Severe Acute MalnutritionNCT04174846
Comparison of Treatment of SAM in Children 6-59 Months With RUTF and RUSF in Umerkot, Sindh, Pakistan
A study testing Ready-to-use therapeutic food (RUTF) and Ready-to-use-supplementary food (RUSF) in people with Severe Acute Malnutrition, run by Aga Khan University at 1 site in Pakistan.
Trial summary
In Pakistan, around 15% of children under five are wasted, which is almost twice that of the global prevalence 7.5%. There is a demand for a reliable and consistent locally available severe acute malnutrition (SAM) treatment option since currently the only option is to use an imported ready-to-use-therapeutic food… 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?
- Ready-to-use therapeutic food (RUTF) and Ready-to-use-supplementary food (RUSF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2021to 31 Oct 2021
- 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 with SAM, i.e. MUAC <11.5 cm
- Bilateral pitting oedema (+,++)
- Appetite
- Without medical complications
Who cannot join
- Children will be excluded if they were simultaneously involved in another research trial or supplemental feeding program
- Developmentally delayed
- Have a chronic debilitating illness such as cerebral palsy (not including HIV or TB)
- Had a history of milk or peanut allergy.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
10 Basic Health Units (BHUs) operating by People's Primary Healthcare Initiative (PPHI)
Umarkot, Sindh
About this study
Official title: Comparison of Treatment of Severe Acute Malnutrition in Children 6-59 Months Old With Ready-to-use Therapeutic Food and Ready-to-use-supplementary Food: An Individual Randomized, Double-Blind, Controlled, Clinical Non-Inferiority Trial
In Pakistan, around 15% of children under five are wasted, which is almost twice that of the global prevalence 7.5%. There is a demand for a reliable and consistent locally available severe acute malnutrition (SAM) treatment option since currently the only option is to use an imported ready-to-use-therapeutic food (RUTF). While imported RUTF is successful for treatment of children with SAM, Pakistan is often faced with supply chain issues and consequentially management of SAM with RUTF is unreliable. The World Food Programme (WFP)'s work in Pakistan supports government-led efforts to improve food and nutrition security, including the development of Acha Mum, a chickpea containing lipid-based ready-to-use-food. Acha Mum replaces the peanut in standard RUTF formulation with chickpea, a locally available legume. Acha Mum is well accepted by children in Pakistan and is currently being used as a treatment for children with moderate acute malnutrition (MAM) in targeted supplementary feeding programs (TSFP) throughout the country. The broad objective of this clinical trial is to test the effectiveness of a chickpea-based specialized nutritious food Acha Mum, compared to a standard RUTF for the treatment of SAM. The study will be conducted in 10 basic health units (BHUs) operating by PPHI in Umerkot district of Sindh, Pakistan. This will be an individual randomized, double-blinded, controlled clinical non-inferiority trial assessing the treatment of SAM with one of two therapeutic foods. A total of 1700 children will be part of the study (850 children in RUTF and 850 children in Acha Mum group). Children aged 6-59 months with SAM, i.e. MUAC <11.5 cm and/or with bilateral pitting oedema (+, ++), with appetite and without medical complications presenting at selected rural therapeutic feeding clinics. The primary outcome is recovery from SAM, defined as: MUAC ≥ 11.5cm (for two consecutive weekly visits), clinically well, no bilateral pitting oedema (for two consecutive weekly visits). The secondary outcomes include neurocognitive performance after first 4 weeks of treatment as assessed by eye tracking and infant problem solving; changes in MUAC, weight, and length; time to recovery from SAM; time to recovery from MAM defined as achieved a MUAC ≥12.5 cm; relapse into MAM; relapse into SAM and any adverse events.
Read the detailed description
Rationale: In Pakistan, around 15% of children under five are wasted, which is almost twice that of the global prevalence 7.5%. There is a demand for a reliable and consistent locally available severe acute malnutrition (SAM) treatment option since currently the only option is to use an imported ready-to-use-therapeutic food (RUTF). While imported RUTF is successful for treatment of children with SAM, Pakistan is often faced with supply chain issues and consequentially management of SAM with RUTF is unreliable. The World Food Programme (WFP)'s work in Pakistan supports government-led efforts to improve food and nutrition security, including the development of Acha Mum, a chickpea containing lipid-based ready-to-use-food. Acha Mum replaces the peanut in standard RUTF formulation with chickpea, a locally available legume. Acha Mum is well accepted by children in Pakistan and is currently being used as a treatment for children with moderate acute malnutrition (MAM) in targeted supplementary feeding programs (TSFP) throughout the country.
Objectives: The broad objective of this clinical trial is to test the effectiveness of a chickpea-based specialized nutritious food Acha Mum, compared to a standard RUTF for the treatment of SAM.
Study Area: The study will be conducted in 10 basic health units (BHUs) operating by PPHI in Umerkot district of Sindh, Pakistan.
Study Design: This will be an individual randomized, double-blinded, controlled clinical non-inferiority trial assessing the treatment of SAM with one of two therapeutic foods.
Sample Size: A total of 1700 children will be part of the study (850 children in RUTF and 850 children in Acha Mum group).
Study Population: Children aged 6-59 months with SAM, i.e. MUAC <11.5 cm and/or with bilateral pitting oedema (+, ++), with appetite and without medical complications presenting at selected rural therapeutic feeding clinics.
Timeline: The duration of study will be 24 months (3 months for protocol and tool development, 18 months for enrollment and follow-ups and 3 months for data cleaning, analysis and report writing.
Expected outcomes: The primary outcome is recovery from SAM, defined as: MUAC ≥ 11.5cm (for two consecutive weekly visits), clinically well, no bilateral pitting oedema (for two consecutive weekly visits). The secondary outcomes include neurocognitive performance after first 4 weeks of treatment as assessed by eye tracking and infant problem solving; changes in MUAC, weight, and length; time to recovery from SAM; time to recovery from MAM defined as achieved a MUAC ≥12.5 cm; relapse into MAM; relapse into SAM and any adverse events.
- Conditions
- Severe Acute Malnutrition
- Being tested
- Ready-to-use therapeutic food (RUTF), Ready-to-use-supplementary food (RUSF)
- 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.
Ready-to-use therapeutic food (RUTF)Dietary supplement
SAM children will receive approximately 190 kcal/kg/day of standard RUTF
Ready-to-use-supplementary food (RUSF)Dietary supplement
SAM children will receive approximately 190 kcal/kg/day of Acha Mum (AM-RUSF)
| Study group | Role | What they receive |
|---|---|---|
| Treatment of SAM children with RUTF | Active comparator | Treatment of severe acute malnutrition (SAM) in children 6-59 months old with standard ready-to-use therapeutic food (RUTF) Receives: Dietary Supplement: Ready-to-use therapeutic food (RUTF) |
| Treatment of SAM children with RUSF | Experimental | Treatment of severe acute malnutrition (SAM) in children 6-59 months old with ready-to-use-supplementary food (RUSF) Receives: Dietary Supplement: Ready-to-use-supplementary food (RUSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery rate from SAM
Number of children recovered from SAM, defined as: MUAC ≥ 11.5cm (for two consecutive weekly visits), clinically well, no bilateral pitting oedema (for two consecutive weekly visits)
Measured: 12 weeks
Secondary outcomes (9)
Neurocognitive performance after first 4 weeks of treatment
Neurocognitive performance after first 4 weeks of treatment as assessed by eye tracking and infant problem solving
Measured: 4 weeks
Changes in mid-upper arm circumference (MUAC)
Changes in MUAC will be assessed by cm \& mm
Measured: 12 weeks
Changes in weight
Changes in weight will be assessed by grams
Measured: 12 weeks
Changes in length
Changes in length will be assessed by cm
Measured: 12 weeks
Time to recovery from SAM
Time to recovery from MAM defined as achieved a MUAC ≥12.5 cm
Measured: 12 weeks
Relapse rate into SAM
Number of relapse in SAM will be identified after 3 months of follow-up
Measured: 24 weeks
Non-responder children
Number of children who non-responded will be assessed in follow-up visits
Measured: 12 weeks
Defaulter children
Number of defaulter children during the study will be assessed by follow-up visits
Measured: 24 weeks
Adverse events
Number of adverse events (if any) will be identified in follow-up visits
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study startJan 2021 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Why it stopped: Due to COVID-19
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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- United Nations World Food Programme (WFP), People's Primary Healthcare Initiative (PPHI), Sindh
- Responsible party
- Principal investigator, Dr Sajid Bashir Soofi, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174846
- Sponsor's protocol ID
- 2019-1615-4895
- Status last verified
- May 2021
- First submitted
- 21 Nov 2019
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment of Severe Acute Malnutrition in Children 6-59 Months Old With Ready-to-use Therapeutic Food and Ready-to-use-supplementary Food: An Individual Randomized, Double-Blind, Controlled, Clinical Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT04174846
- Acronym / sponsor ID
- 2019-1615-4895
- Conditions
- Severe Acute Malnutrition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- United Nations World Food Programme (WFP), People's Primary Healthcare Initiative (PPHI), Sindh
- Study start
- Jan 2021 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 22 Nov 2019 (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.
In Pakistan, around 15% of children under five are wasted, which is almost twice that of the global prevalence 7.5%. There is a demand for a reliable and consistent locally available severe acute malnutrition (SAM) treatment option since currently the only option is to use an imported ready-to-use-therapeutic food (RUTF). While imported RUTF is successful for treatment of children with SAM, Pakistan is often faced with supply chain issues and consequentially management of SAM with RUTF is unreliable. The World Food Programme (WFP)'s work in Pakistan supports government-led efforts to improve food and nutrition security, including the development of Acha Mum, a chickpea containing lipid-based ready-to-use-food. Acha Mum replaces the peanut in standard RUTF formulation with chickpea, a locally available legume. Acha Mum is well accepted by children in Pakistan and is currently being used as a treatment for children with moderate acute malnutrition (MAM) in targeted supplementary feeding programs (TSFP) throughout the country. The broad objective of this clinical trial is to test the effectiveness of a chickpea-based specialized nutritious food Acha Mum, compared to a standard RUTF for the treatment of SAM. The study will be conducted in 10 basic health units (BHUs) operating by PPHI in Umerkot district of Sindh, Pakistan. This will be an individual randomized, double-blinded, controlled clinical non-inferiority trial assessing the treatment of SAM with one of two therapeutic foods. A total of 1700 children will be part of the study (850 children in RUTF and 850 children in Acha Mum group). Children aged 6-59 months with SAM, i.e. MUAC <11.5 cm and/or with bilateral pitting oedema (+, ++), with appetite and without medical complications presenting at selected rural therapeutic feeding clinics. The primary outcome is recovery from SAM, defined as: MUAC ≥ 11.5cm (for two consecutive weekly visits), clinically well, no bilateral pitting oedema (for two consecutive weekly visits). The secondary outcomes include neurocognitive performance after first 4 weeks of treatment as assessed by eye tracking and infant problem solving; changes in MUAC, weight, and length; time to recovery from SAM; time to recovery from MAM defined as achieved a MUAC ≥12.5 cm; relapse into MAM; relapse into SAM and any adverse events.
Detailed description
Rationale: In Pakistan, around 15% of children under five are wasted, which is almost twice that of the global prevalence 7.5%. There is a demand for a reliable and consistent locally available severe acute malnutrition (SAM) treatment option since currently the only option is to use an imported ready-to-use-therapeutic food (RUTF). While imported RUTF is successful for treatment of children with SAM, Pakistan is often faced with supply chain issues and consequentially management of SAM with RUTF is unreliable. The World Food Programme (WFP)'s work in Pakistan supports government-led efforts to improve food and nutrition security, including the development of Acha Mum, a chickpea containing lipid-based ready-to-use-food. Acha Mum replaces the peanut in standard RUTF formulation with chickpea, a locally available legume. Acha Mum is well accepted by children in Pakistan and is currently being used as a treatment for children with moderate acute malnutrition (MAM) in targeted supplementary feeding programs (TSFP) throughout the country.
Objectives: The broad objective of this clinical trial is to test the effectiveness of a chickpea-based specialized nutritious food Acha Mum, compared to a standard RUTF for the treatment of SAM.
Study Area: The study will be conducted in 10 basic health units (BHUs) operating by PPHI in Umerkot district of Sindh, Pakistan.
Study Design: This will be an individual randomized, double-blinded, controlled clinical non-inferiority trial assessing the treatment of SAM with one of two therapeutic foods.
Sample Size: A total of 1700 children will be part of the study (850 children in RUTF and 850 children in Acha Mum group).
Study Population: Children aged 6-59 months with SAM, i.e. MUAC <11.5 cm and/or with bilateral pitting oedema (+, ++), with appetite and without medical complications presenting at selected rural therapeutic feeding clinics.
Timeline: The duration of study will be 24 months (3 months for protocol and tool development, 18 months for enrollment and follow-ups and 3 months for data cleaning, analysis and report writing.
Expected outcomes: The primary outcome is recovery from SAM, defined as: MUAC ≥ 11.5cm (for two consecutive weekly visits), clinically well, no bilateral pitting oedema (for two consecutive weekly visits). The secondary outcomes include neurocognitive performance after first 4 weeks of treatment as assessed by eye tracking and infant problem solving; changes in MUAC, weight, and length; time to recovery from SAM; time to recovery from MAM defined as achieved a MUAC ≥12.5 cm; relapse into MAM; relapse into SAM and any adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment of SAM children with RUTF | Active comparator | Dietary Supplement: Ready-to-use therapeutic food (RUTF)Treatment of severe acute malnutrition (SAM) in children 6-59 months old with standard ready-to-use therapeutic food (RUTF) |
| Treatment of SAM children with RUSF | Experimental | Dietary Supplement: Ready-to-use-supplementary food (RUSF)Treatment of severe acute malnutrition (SAM) in children 6-59 months old with ready-to-use-supplementary food (RUSF) |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-59 months with SAM, i.e. MUAC <11.5 cm
- Bilateral pitting oedema (+,++)
- Appetite
- Without medical complications
Key exclusion criteria (4 listed)
- Children will be excluded if they were simultaneously involved in another research trial or supplemental feeding program
- Developmentally delayed
- Have a chronic debilitating illness such as cerebral palsy (not including HIV or TB)
- Had a history of milk or peanut allergy.
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 |
|---|---|---|
| Ready-to-use therapeutic food (RUTF)SAM children will receive approximately 190 kcal/kg/day of standard RUTF | Dietary supplement | Treatment of SAM children with RUTF |
| Ready-to-use-supplementary food (RUSF)SAM children will receive approximately 190 kcal/kg/day of Acha Mum (AM-RUSF) | Dietary supplement | Treatment of SAM children with RUSF |
Primary outcome
Recovery rate from SAM
Time frame: 12 weeks
Number of children recovered from SAM, defined as: MUAC ≥ 11.5cm (for two consecutive weekly visits), clinically well, no bilateral pitting oedema (for two consecutive weekly visits)
9 secondary outcomes
Neurocognitive performance after first 4 weeks of treatment
Time frame: 4 weeks
Changes in mid-upper arm circumference (MUAC)
Time frame: 12 weeks
Changes in weight
Time frame: 12 weeks
Changes in length
Time frame: 12 weeks
Time to recovery from SAM
Time frame: 12 weeks
Relapse rate into SAM
Time frame: 24 weeks
Non-responder children
Time frame: 12 weeks
Defaulter children
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Individual participant dataSharing planned: No. De-identified data will be shared
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ready-to-use therapeutic food (RUTF) and Ready-to-use-supplementary food (RUSF) in people with Severe Acute Malnutrition, run by Aga Khan University 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 4 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: withdrawn, as of the sponsor's last update on 19 May 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Recovery rate from SAM (time frame: 12 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 19 May 2021.