MalnutritionNCT03407326
Comparison of an Alternative Therapeutic Food for the International Food Aid Market to a Standard Ready-to-use Therapeutic Food (RUTF) for the Treatment of Severe Acute Malnutrition in Children
A study testing Alternative RUTF and Standard RUTF in people with Malnutrition, run by Washington University School of Medicine at 1 site in Sierra Leone.
Trial summary
In this clinical non-inferiority trial, two foods will be compared for the treatment of SAM, testing the hypothesis that the difference in recovery rates and growth between the two test groups will be no greater than 5 percent. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Alternative RUTF and Standard RUTF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,568 participants
- Where
- 1 siteSierra Leone
- Study dates
- 16 Oct 2018to 2 Sep 2019
- 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 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- children currently involved in another research trial or feeding program
- developmentally delayed
- chronic debilitating illness (such as cerebral palsy)
- history of peanut or milk allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of an Alternative Therapeutic Food for the International Food Aid Market to a Standard Ready-to-use Therapeutic Food (RUTF) for the Treatment of Severe Acute Malnutrition in Children of the Western Rural Region and Pujehun District of Sierra Leone
In this clinical non-inferiority trial, two foods will be compared for the treatment of SAM, testing the hypothesis that the difference in recovery rates and growth between the two test groups will be no greater than 5 percent.
Read the detailed description
This will be a randomised, triple-blinded, controlled clinical non-inferiority trial assessing the treatment of SAM with one of two therapeutic foods until the child is recovered or for a period of up to 12 weeks.
Subjects will be recruited from rural health clinics in the Western Rural Region and Pujehun District of Sierra Leone, due to the limited accessibility of treatment programs in this area; investigators believe a clinical trial in this district will be beneficial.
Sierra Leonean children aged 6-59 months with uncomplicated SAM (with WHZ < -3, MUAC of <11.5 cm, or bipedal edema) will be recruited at health clinics in the Western Rural Region and Pujehun District. A total of 1,300 children will be enrolled for a total sample size of 1,262 (631 per treatment) from 30 PHU centers, to detect a 5% difference in recovery rates between any two foods, with 95% sensitivity and 80% power, assuming that the standard recovery rate is 85% and a binary non-inferiority test.
After screening and enrolment, each child's participation will last up to 12 weeks. If a child recovers before the end of the 12-week period, a child's WHZ reaches and stays above -2 for two consecutive visits without edema, the child will graduate from the study. No study food products will be given to children after 12 weeks of participation; those who have not recovered will be taken for inpatient treatment. Children will enter the study on a rolling enrolment basis and will continue to be enrolled until 1,300 children complete the study.
Random allocation of food intervention will be conducted by nurses who will have the caregiver draw opaque envelopes containing one of 4 colours. Caretakers chose a sealed envelope that contains 1 of 4 colours: 2 of these colours correspond to the control food and 2 to the experimental food. The colour will be recorded separately from the child's clinical measurements and researchers involved in the randomization process do not know which colour corresponds to which food corresponding to one of the therapeutic foods. The code will be accessible only to the food distribution personnel, who do not assess participant outcomes or eligibility. Investigators performing clinical assessments and caretakers will be blinded to the child's assigned food group.
A sub-set of participants in the main study will undergo eye-tracking testing to evaluate neurocognitive function and recovery in children with severe acute malnutrition after receiving therapeutic food.
- Conditions
- Malnutrition
- Being tested
- Alternative RUTF, Standard RUTF
- Keywords
- severe acute malnutrition, SAM
- Medical subject headings
- Malnutrition, Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative RUTFDietary supplement
The alternative RUTF contains oat, peanuts, sugar, milk powder, vegetable oil as well as premix containing concentrated minerals and vitamins and emulsifier.
Standard RUTFDietary supplement
Standard RUTF contains peanut paste, sugar, non-fat dried milk (NFDM), vegetable oil, a premix containing concentrated minerals and vitamins, and emulsifier.
| Study group | Role | What they receive |
|---|---|---|
| Alternative | Experimental | Participants will receive approximately 190 kcal/kg/day of alternative RUTF till recovery or up to 12 weeks of treatment. Receives: Dietary Supplement: Alternative RUTF |
| Standard | Active comparator | Participants will receive approximately 190 kcal/kg/day of standard RUTF till recovery or up to 12 weeks of treatment. Receives: Dietary Supplement: Standard RUTF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid-upper-arm circumference
MUAC ≥ 12.5
Measured: 2 to 12 weeks
Weight-for-height z score
WHZ≥-2
Measured: 2 to 12 weeks
Secondary outcomes (1)
Adverse symptoms
stomach pain, vomiting, diarrhoea, rash or fever
Measured: 2 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start16 Oct 2018
- Primary completion2 Sep 2019
- Study completion2 Sep 2019
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 MalnutritionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Children's Investment Fund Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407326
- Sponsor's protocol ID
- 201710147
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hendrixson DT, Godbout C, Los A, Callaghan-Gillespie M, Mui M, Wegner D, Bryant T, Koroma A, Manary MJ. Treatment of severe acute malnutrition with oat or standard ready-to-use therapeutic food: a triple-blind, randomised controlled clinical trial. Gut. 2020 Dec;69(12):2143-2149. doi: 10.1136/gutjnl-2020-320769. Epub 2020 Mar 16.
PubMed 32179568
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an Alternative Therapeutic Food for the International Food Aid Market to a Standard Ready-to-use Therapeutic Food (RUTF) for the Treatment of Severe Acute Malnutrition in Children of the Western Rural Region and Pujehun District of Sierra Leone
- ClinicalTrials.gov ID
- NCT03407326
- Acronym / sponsor ID
- 201710147
- Conditions
- Malnutrition
- Keywords
- severe acute malnutrition, SAM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,568 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Children's Investment Fund Foundation
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 2 Sep 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 23 Jan 2018 (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 this clinical non-inferiority trial, two foods will be compared for the treatment of SAM, testing the hypothesis that the difference in recovery rates and growth between the two test groups will be no greater than 5 percent.
Detailed description
This will be a randomised, triple-blinded, controlled clinical non-inferiority trial assessing the treatment of SAM with one of two therapeutic foods until the child is recovered or for a period of up to 12 weeks.
Subjects will be recruited from rural health clinics in the Western Rural Region and Pujehun District of Sierra Leone, due to the limited accessibility of treatment programs in this area; investigators believe a clinical trial in this district will be beneficial.
Sierra Leonean children aged 6-59 months with uncomplicated SAM (with WHZ < -3, MUAC of <11.5 cm, or bipedal edema) will be recruited at health clinics in the Western Rural Region and Pujehun District. A total of 1,300 children will be enrolled for a total sample size of 1,262 (631 per treatment) from 30 PHU centers, to detect a 5% difference in recovery rates between any two foods, with 95% sensitivity and 80% power, assuming that the standard recovery rate is 85% and a binary non-inferiority test.
After screening and enrolment, each child's participation will last up to 12 weeks. If a child recovers before the end of the 12-week period, a child's WHZ reaches and stays above -2 for two consecutive visits without edema, the child will graduate from the study. No study food products will be given to children after 12 weeks of participation; those who have not recovered will be taken for inpatient treatment. Children will enter the study on a rolling enrolment basis and will continue to be enrolled until 1,300 children complete the study.
Random allocation of food intervention will be conducted by nurses who will have the caregiver draw opaque envelopes containing one of 4 colours. Caretakers chose a sealed envelope that contains 1 of 4 colours: 2 of these colours correspond to the control food and 2 to the experimental food. The colour will be recorded separately from the child's clinical measurements and researchers involved in the randomization process do not know which colour corresponds to which food corresponding to one of the therapeutic foods. The code will be accessible only to the food distribution personnel, who do not assess participant outcomes or eligibility. Investigators performing clinical assessments and caretakers will be blinded to the child's assigned food group.
A sub-set of participants in the main study will undergo eye-tracking testing to evaluate neurocognitive function and recovery in children with severe acute malnutrition after receiving therapeutic food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternative | Experimental | Dietary Supplement: Alternative RUTFParticipants will receive approximately 190 kcal/kg/day of alternative RUTF till recovery or up to 12 weeks of treatment. |
| Standard | Active comparator | Dietary Supplement: Standard RUTFParticipants will receive approximately 190 kcal/kg/day of standard RUTF till recovery or up to 12 weeks of treatment. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- children currently involved in another research trial or feeding program
- developmentally delayed
- chronic debilitating illness (such as cerebral palsy)
- history of peanut or milk 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 |
|---|---|---|
| Alternative RUTFThe alternative RUTF contains oat, peanuts, sugar, milk powder, vegetable oil as well as premix containing concentrated minerals and vitamins and emulsifier. | Dietary supplement | Alternative |
| Standard RUTFStandard RUTF contains peanut paste, sugar, non-fat dried milk (NFDM), vegetable oil, a premix containing concentrated minerals and vitamins, and emulsifier. | Dietary supplement | Standard |
Primary outcome
Mid-upper-arm circumference
Time frame: 2 to 12 weeks
MUAC ≥ 12.5
Weight-for-height z score
Time frame: 2 to 12 weeks
WHZ≥-2
1 secondary outcome
Adverse symptoms
Time frame: 2 to 12 weeks
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 13 Jan 2020.
- Derived from this study: PubMed 32179568Hendrixson DT, Godbout C, Los A, Callaghan-Gillespie M, Mui M, Wegner D, Bryant T, Koroma A, Manary MJ. Treatment of severe acute malnutrition with oat or standard ready-to-use therapeutic food: a triple-blind, randomised controlled clinical trial. Gut. 2020 Dec;69(12):2143-2149. doi: 10.1136/gutjnl-2020-320769. Epub 2020 Mar 16.
- Individual participant dataSharing planned: No
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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 Alternative RUTF and Standard RUTF in people with Malnutrition, run by Washington University School of Medicine at 1 site in Sierra Leone.
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 0 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 13 Jan 2020. 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 Sierra Leone. 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?
Mid-upper-arm circumference (time frame: 2 to 12 weeks). The study lists 2 primary outcomes in all. 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 NCT03407326, 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 13 Jan 2020.