Severe Acute MalnutritionPhase 2/3NCT01634009
Soy-Ready to Use Therapeutic Food (RUTF) in Severely Malnourished Children
A Phase 2/3 study testing Soy-based RUTF (in double blind design) in people with Severe Acute Malnutrition and Severe Wasting, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
SAM defined by having weight-for-height (WH) less than - 3 Z score or bi-pedal nutritional edema is an important cause of death in children globally including Bangladesh. The death rate among children hospitalized for SAM is still high. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Severe Acute Malnutrition, Severe Wasting, Community Based Nutritional Management
- What is being tested?
- Soy-based RUTF (in double blind design)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteBangladesh
- Study dates
- Jul 2012to Dec 2016
- Phase
- Phase 2/3
- 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 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children (both boys and girls) with SAM defined by WH < -3 Z score of WHO standard,
- completed acute (stabilization) phase management,
- clinically well,
- no edema and regaining appetite and aged 6 to 60 months will be included. - additional enrollment criteria will be as follows:
- no signs of concurrent infection,
- mothers/caregivers agreed to stay in their current address for next 4 months (for tracking the children)
Who cannot join
- failure to obtain consent from parents or caretakers;
- children without any fixed address;
- children with tuberculosis or any congenital/acquired disorder affecting growth i.e. trisomy-21 or cerebral palsy;
- children on an exclusion diet for the treatment of persistent diarrhea,
- having history of soy, peanut or milk protein allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ready to Use Therapeutic Food Using Soy Protein Isolate in Under-5 Children With Severe Acute Malnutrition in Bangladesh
SAM defined by having weight-for-height (WH) less than - 3 Z score or bi-pedal nutritional edema is an important cause of death in children globally including Bangladesh. The death rate among children hospitalized for SAM is still high. Severe malnutrition in children can be successfully treated by using WHO guidelines with or without minor modification. Since the Community Based Therapeutic Care (CTC)/CMAM approach was developed, the use of RUTF for the treatment of children with SAM has gained ground, and huge amounts of RUTF are used particularly in African countries. RUTFs are an energy-dense lipid paste enriched with vitamins and minerals. The typical composition (ingredient % of weight) of RUTF is whole milk powder 30%; sugar 28%; vegetable oil 15.4%; peanut paste 25%; and mineral vitamin mix 1.6%. Although the CTC model promises treatment of SAM at a considerably lower cost than the previous inpatient model, the cost of RUTF is still considered a significant barrier to universal roll-out of SAM treatment and has made CTC implementation too expensive in many high-need countries.
The single most expensive raw ingredient in RUTF is milk powder, contributing around 50% of raw ingredient cost or between 30-35% of the total cost of the final product. Isolated soy protein has a cost per kg protein that normally is below that of skim or whole milk powder, and can thus reduce the total cost of RUTF. In addition, isolated soy protein (ISP) is a high quality, complete protein that meets the daily protein requirements of growing children and adults. ISP is a highly digestible protein [FAO/WHO, 1991] with an amino acid profile that has been shown to achieve a Protein Digestibility-Corrected Amino Acid Score (PDCAAS) of 1.00, comparable to milk and eggs, and has been shown to maintain nitrogen balance when fed as the sole protein source at minimum recommended intake levels.
To compare the efficacy (weight gain, rate of weight gain and change of lean body mass) of the standard RUTF and an RUTF made from ISP (Soy-RUTF) through a randomized double masked intervention trial 300 SAM children aged 6 to 59 months after completion of their stabilization phase from the Dhaka Hospital of icddr,b Bangladesh will be studied. They will randomly receive standard- or Soy-RUTF as take home and followed up (weekly until achieving -2 WHZ, and thereafter fortnightly until achieving -1 WHZ) at the nutrition follow up unit at the outpatient department of this Dhaka Hospital of icddr,b.
- Being tested
- Soy-based RUTF (in double blind design)
- Keywords
- Severe acute malnutrition, Ready to use therapeutic food, Soy protein, Community based management, Efficacy, Management of Children with SAM in Bangladesh
- Medical subject headings
- Severe Acute Malnutrition, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy-based RUTF (in double blind design)Dietary supplement
Also called Soy-based RUTF is the intervention
Soy-based RUTF will be given in double blind manner
| Study group | Role | What they receive |
|---|---|---|
| Standard RUTF (control) | Active comparator | Children will receive standard RUTF in this arm and will be considered as control arm Receives: Dietary Supplement: Soy-based RUTF (in double blind design) |
| Standard RUTF | No intervention | Will act as control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy (rate of weight gain)
By 31st December 2014 we shall be able to complete the enrollment, data analyses and preliminary/draft report writting.
Measured: 31 December 2014 (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MD IQBAL HOSSAIN, DCH, PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634009
- Sponsor's protocol ID
- PR-09038
- Status last verified
- Jun 2016
- First submitted
- 12 Jun 2012
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hossain MI, Huq S, Islam MM, Ahmed T. Acceptability and efficacy of ready-to-use therapeutic food using soy protein isolate in under-5 children suffering from severe acute malnutrition in Bangladesh: a double-blind randomized non-inferiority trial. Eur J Nutr. 2020 Apr;59(3):1149-1161. doi: 10.1007/s00394-019-01975-w. Epub 2019 Apr 29.
PubMed 31037340
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ready to Use Therapeutic Food Using Soy Protein Isolate in Under-5 Children With Severe Acute Malnutrition in Bangladesh
- ClinicalTrials.gov ID
- NCT01634009
- Acronym / sponsor ID
- PR-09038
- Keywords
- Severe acute malnutrition, Ready to use therapeutic food, Soy protein, Community based management, Efficacy, Management of Children with SAM in Bangladesh
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Jul 2012 (estimated)
- 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.
SAM defined by having weight-for-height (WH) less than - 3 Z score or bi-pedal nutritional edema is an important cause of death in children globally including Bangladesh. The death rate among children hospitalized for SAM is still high. Severe malnutrition in children can be successfully treated by using WHO guidelines with or without minor modification. Since the Community Based Therapeutic Care (CTC)/CMAM approach was developed, the use of RUTF for the treatment of children with SAM has gained ground, and huge amounts of RUTF are used particularly in African countries. RUTFs are an energy-dense lipid paste enriched with vitamins and minerals. The typical composition (ingredient % of weight) of RUTF is whole milk powder 30%; sugar 28%; vegetable oil 15.4%; peanut paste 25%; and mineral vitamin mix 1.6%. Although the CTC model promises treatment of SAM at a considerably lower cost than the previous inpatient model, the cost of RUTF is still considered a significant barrier to universal roll-out of SAM treatment and has made CTC implementation too expensive in many high-need countries.
The single most expensive raw ingredient in RUTF is milk powder, contributing around 50% of raw ingredient cost or between 30-35% of the total cost of the final product. Isolated soy protein has a cost per kg protein that normally is below that of skim or whole milk powder, and can thus reduce the total cost of RUTF. In addition, isolated soy protein (ISP) is a high quality, complete protein that meets the daily protein requirements of growing children and adults. ISP is a highly digestible protein [FAO/WHO, 1991] with an amino acid profile that has been shown to achieve a Protein Digestibility-Corrected Amino Acid Score (PDCAAS) of 1.00, comparable to milk and eggs, and has been shown to maintain nitrogen balance when fed as the sole protein source at minimum recommended intake levels.
To compare the efficacy (weight gain, rate of weight gain and change of lean body mass) of the standard RUTF and an RUTF made from ISP (Soy-RUTF) through a randomized double masked intervention trial 300 SAM children aged 6 to 59 months after completion of their stabilization phase from the Dhaka Hospital of icddr,b Bangladesh will be studied. They will randomly receive standard- or Soy-RUTF as take home and followed up (weekly until achieving -2 WHZ, and thereafter fortnightly until achieving -1 WHZ) at the nutrition follow up unit at the outpatient department of this Dhaka Hospital of icddr,b.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard RUTF (control) | Active comparator | Dietary Supplement: Soy-based RUTF (in double blind design)Children will receive standard RUTF in this arm and will be considered as control arm |
| Standard RUTF | No intervention | –Will act as control |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- children (both boys and girls) with SAM defined by WH < -3 Z score of WHO standard,
- completed acute (stabilization) phase management,
- clinically well,
- no edema and regaining appetite and aged 6 to 60 months will be included. - additional enrollment criteria will be as follows:
Key exclusion criteria (5 listed)
- failure to obtain consent from parents or caretakers;
- children without any fixed address;
- children with tuberculosis or any congenital/acquired disorder affecting growth i.e. trisomy-21 or cerebral palsy;
- children on an exclusion diet for the treatment of persistent diarrhea,
- having history of soy, peanut or milk protein 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 |
|---|---|---|
| Soy-based RUTF (in double blind design)Also: Soy-based RUTF is the interventionSoy-based RUTF will be given in double blind manner | Dietary supplement | Standard RUTF (control) |
Primary outcome
To compare the efficacy (rate of weight gain)
Time frame: 31 December 2014 (up to 3 years)
By 31st December 2014 we shall be able to complete the enrollment, data analyses and preliminary/draft report writting.
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 25 Sep 2017.
- Derived from this study: PubMed 31037340Hossain MI, Huq S, Islam MM, Ahmed T. Acceptability and efficacy of ready-to-use therapeutic food using soy protein isolate in under-5 children suffering from severe acute malnutrition in Bangladesh: a double-blind randomized non-inferiority trial. Eur J Nutr. 2020 Apr;59(3):1149-1161. doi: 10.1007/s00394-019-01975-w. Epub 2019 Apr 29.
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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.
MD IQBAL HOSSAIN, DCH, PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Soy-based RUTF (in double blind design) in people with Severe Acute Malnutrition and Severe Wasting, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 6 inclusion and 5 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 25 Sep 2017. 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 Bangladesh. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To compare the efficacy (rate of weight gain) (time frame: 31 December 2014 (up to 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01634009, which also lists 1 linked publication.
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 25 Sep 2017.