Severe Acute MalnutritionNCT03094247
Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development
A study testing Amoxicillin, HO-RUTF and D-HO-RUTF in people with Severe Acute Malnutrition, run by Washington University School of Medicine at 1 site in Malawi.
Trial summary
An appropriate balance of omega-6 and omega-3 fatty acids is important for support of neurocognitive development in healthy infants and toddlers. In young children recovering from severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status. 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?
- Amoxicillin, HO-RUTF and D-HO-RUTF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,897 participants
- Where
- 1 siteMalawi
- Study dates
- 2 Oct 2017to 23 Mar 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
- 6-59 months
- An acceptable appetite defined by the ability to consume 30 grams RUTF within 20 minutes
- Mid Upper Arm Circumference <11.5 cm, weight-for-height z-score < -3, or bilateral pitting edema on the dorsum of the feet
Who cannot join
- Participation in any other ongoing study or supplementary feeding program
- Children with a chronic medical condition, including cerebral palsy, static encephalopathy, congenital heart disease, gastrointestinal disease, or peanut allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Polyunsaturated Ready-to-use Therapeutic Food for Improved Neurocognitive Outcomes in Severe Acute Malnutrition
An appropriate balance of omega-6 and omega-3 fatty acids is important for support of neurocognitive development in healthy infants and toddlers. In young children recovering from severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status. This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced fatty acids improve the metabolic and neurocognitive effects in young children in Malawi recovering from SAM, yielding new knowledge that also has implications for development of well-nourished children.
- Conditions
- Severe Acute Malnutrition
- Being tested
- Amoxicillin, HO-RUTF, D-HO-RUTF, S-RUTF
- Keywords
- Malnutrition, Micronutrients, Polyunsaturated fatty acids, Ready-to-use therapeutic foods, Omega-3 fatty acids, Peanuts
- Medical subject headings
- Severe Acute Malnutrition, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Also called Amoxil
All patients with severe acute malnutrition will receive a course of amoxicillin.
HO-RUTFDietary supplement
HO-RUTF: Milk, perilla oil, palm oil, white sugar, high oleic peanuts
D-HO-RUTFDietary supplement
D-HO-RUTF: DHA, milk, perilla oil, palm oil, white sugar, high oleic peanuts
S-RUTFDietary supplement
S-RUTF: Milk, canola oil, palm oil, white sugar, standard peanuts
| Study group | Role | What they receive |
|---|---|---|
| Conventional RUTF (S-RUTF) | Active comparator | This is the control group for the study, which will receive the international standard of care therapeutic food. S-RUTF is made with conventional peanuts, which are inherently high in omega-6 linoleic acid. Receives: Drug: Amoxicillin; Dietary Supplement: S-RUTF |
| High oleic RUTF (HO-RUTF) | Experimental | The treatment provided to children randomized to this arm of the study includes nutritional content comparable to S-RUTF with the exception of a low lineoleic acid/high oleic acid ratio formulated with high oleic content peanuts. Receives: Drug: Amoxicillin; Dietary Supplement: HO-RUTF |
| DHA-supplemented HO-RUTF (D-HO-RUTF) | Experimental | The treatment provided to children randomized to this arm of the study mirrors that provided by HO-RUTF with that addition of supplemental DHA at a level higher than attainable with optimal precursors. Receives: Drug: Amoxicillin; Dietary Supplement: D-HO-RUTF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive outcome
Measured by score on the Malawian Developmental Assessment Test (MDAT). The scale is continuous and interval in nature, the range varies by population
- The scale title is "Malawi Developmental Assessment Tool z-score"
- The primary outcome is Global z-score, titled "Global z-sore"
- Secondary outcomes are 4 sub-domain z-scores are titled "Gross motor z-score", "Fine motor z-score", Language z-score", and "Social z-score"
Measured: Time Frame: 4 to 7 months after nutritional outcome
Neurocognitive outcome
Defined by Willatts intention score adapted for field training, 3 problems to be tested. The scale is ordinal in nature, with higher values indicated better scores
- The scale title is "Intention Score"
- Problem 1 is scored 0 - 4
- Problem 2 is scored 0 - 4
- Problem 3 is scored 0 - 8
Measured: Time Frame: within 4 weeks after nutritional outcome
Secondary outcomes (4)
Nutritional recovery
Defined by resolution of edema AND mid-upper arm circumference [MUAC] >12.4cm, AND/OR a weight/height z-score [WHZ] >-3
Measured: Up to 12 weeks following enrollment
Attentional orienting speed
Measured by mean saccade latency to peripheral targets
Measured: 4-7 months after nutritional after nutritional outcome
Adverse Events
Measured by number of days diarrhea and/or rashes.
Measured: Fortnightly follow up visits up to 12 weeks following enrollment
Acceptance of RUTF
Mother's report of if the child ate the food well. This is a yes or no question.
Measured: Fortnightly follow up visits up to 12 weeks following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start2 Oct 2017
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,897 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin, Cornell University, Kamuzu University of Health Sciences
- Responsible party
- Sponsor
- Investigators
- Mark J Manary, MD, Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094247
- Sponsor's protocol ID
- MMPUFA17
- Status last verified
- Jul 2022
- First submitted
- 23 Mar 2017
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article after deidentification will be indefinitely available within 9 months following article publication through The Washington University Open Scholarship Institutional Repository.
Publications
Stephenson K, Callaghan-Gillespie M, Maleta K, Nkhoma M, George M, Park HG, Lee R, Humphries-Cuff I, Lacombe RJS, Wegner DR, Canfield RL, Brenna JT, Manary MJ. Low linoleic acid foods with added DHA given to Malawian children with severe acute malnutrition improve cognition: a randomized, triple-blinded, controlled clinical trial. Am J Clin Nutr. 2022 May 1;115(5):1322-1333. doi: 10.1093/ajcn/nqab363.
PubMed 34726694
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Polyunsaturated Ready-to-use Therapeutic Food for Improved Neurocognitive Outcomes in Severe Acute Malnutrition
- ClinicalTrials.gov ID
- NCT03094247
- Acronym / sponsor ID
- MMPUFA17
- Conditions
- Severe Acute Malnutrition
- Keywords
- Malnutrition, Micronutrients, Polyunsaturated fatty acids, Ready-to-use therapeutic foods, Omega-3 fatty acids, Peanuts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,897 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Texas at Austin, Cornell University, Kamuzu University of Health Sciences
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 29 Mar 2017 (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.
An appropriate balance of omega-6 and omega-3 fatty acids is important for support of neurocognitive development in healthy infants and toddlers. In young children recovering from severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status. This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced fatty acids improve the metabolic and neurocognitive effects in young children in Malawi recovering from SAM, yielding new knowledge that also has implications for development of well-nourished children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional RUTF (S-RUTF) | Active comparator | Drug: Amoxicillin, Dietary Supplement: S-RUTFThis is the control group for the study, which will receive the international standard of care therapeutic food. S-RUTF is made with conventional peanuts, which are inherently high in omega-6 linoleic acid. |
| High oleic RUTF (HO-RUTF) | Experimental | Drug: Amoxicillin, Dietary Supplement: HO-RUTFThe treatment provided to children randomized to this arm of the study includes nutritional content comparable to S-RUTF with the exception of a low lineoleic acid/high oleic acid ratio formulated with high oleic content peanuts. |
| DHA-supplemented HO-RUTF (D-HO-RUTF) | Experimental | Drug: Amoxicillin, Dietary Supplement: D-HO-RUTFThe treatment provided to children randomized to this arm of the study mirrors that provided by HO-RUTF with that addition of supplemental DHA at a level higher than attainable with optimal precursors. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6-59 months
- An acceptable appetite defined by the ability to consume 30 grams RUTF within 20 minutes
- Mid Upper Arm Circumference <11.5 cm, weight-for-height z-score < -3, or bilateral pitting edema on the dorsum of the feet
Key exclusion criteria (2 listed)
- Participation in any other ongoing study or supplementary feeding program
- Children with a chronic medical condition, including cerebral palsy, static encephalopathy, congenital heart disease, gastrointestinal disease, 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 |
|---|---|---|
| AmoxicillinAlso: AmoxilAll patients with severe acute malnutrition will receive a course of amoxicillin. | Drug | Conventional RUTF (S-RUTF), DHA-supplemented HO-RUTF (D-HO-RUTF), High oleic RUTF (HO-RUTF) |
| HO-RUTFHO-RUTF: Milk, perilla oil, palm oil, white sugar, high oleic peanuts | Dietary supplement | High oleic RUTF (HO-RUTF) |
| D-HO-RUTFD-HO-RUTF: DHA, milk, perilla oil, palm oil, white sugar, high oleic peanuts | Dietary supplement | DHA-supplemented HO-RUTF (D-HO-RUTF) |
| S-RUTFS-RUTF: Milk, canola oil, palm oil, white sugar, standard peanuts | Dietary supplement | Conventional RUTF (S-RUTF) |
Primary outcome
Neurocognitive outcome
Time frame: Time Frame: 4 to 7 months after nutritional outcome
Measured by score on the Malawian Developmental Assessment Test (MDAT). The scale is continuous and interval in nature, the range varies by population * The scale title is "Malawi Developmental Assessment Tool z-score" * The primary outcome is Global z-score, titled "Global z-sore" * Secondary outcomes are 4 sub-domain z-scores are titled "Gross motor z-score", "Fine motor z-score", Language z-score", and "Social z-score"
Neurocognitive outcome
Time frame: Time Frame: within 4 weeks after nutritional outcome
Defined by Willatts intention score adapted for field training, 3 problems to be tested. The scale is ordinal in nature, with higher values indicated better scores * The scale title is "Intention Score" * Problem 1 is scored 0 - 4 * Problem 2 is scored 0 - 4 * Problem 3 is scored 0 - 8
4 secondary outcomes
Nutritional recovery
Time frame: Up to 12 weeks following enrollment
Attentional orienting speed
Time frame: 4-7 months after nutritional after nutritional outcome
Adverse Events
Time frame: Fortnightly follow up visits up to 12 weeks following enrollment
Acceptance of RUTF
Time frame: Fortnightly follow up visits up to 12 weeks following enrollment
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 19 Jul 2022.
- Derived from this study: PubMed 34726694Stephenson K, Callaghan-Gillespie M, Maleta K, Nkhoma M, George M, Park HG, Lee R, Humphries-Cuff I, Lacombe RJS, Wegner DR, Canfield RL, Brenna JT, Manary MJ. Low linoleic acid foods with added DHA given to Malawian children with severe acute malnutrition improve cognition: a randomized, triple-blinded, controlled clinical trial. Am J Clin Nutr. 2022 May 1;115(5):1322-1333. doi: 10.1093/ajcn/nqab363.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article after deidentification will be indefinitely available within 9 months following article publication through The Washington University Open Scholarship Institutional Repository.
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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.
Mark J Manary, MD study chair
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin, HO-RUTF and D-HO-RUTF in people with Severe Acute Malnutrition, run by Washington University School of Medicine at 1 site in Malawi.
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 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: finished, as of the sponsor's last update on 19 Jul 2022. 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 Malawi. 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?
Neurocognitive outcome (time frame: Time Frame: 4 to 7 months after nutritional outcome). 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 NCT03094247, 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 19 Jul 2022.