KwashiorkorNCT02053857
Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition
A study testing RUTF, RUTF-P and Amoxicillin in people with Kwashiorkor and Marasmus, run by Washington University School of Medicine at 1 site in Malawi.
Trial summary
To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as standard RUTF. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Kwashiorkor, Marasmus
- What is being tested?
- RUTF, RUTF-P and Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteMalawi
- Study dates
- Feb 2014to Jul 2014
- 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
- kwashiorkor and/or marasmus
- 6-59 months of age
- lives in local area near enrollment site
Who cannot join
- recent (<4 months) therapeutic feeding for moderate or severe acute malnutrition
- chronic medical condition (eg, Down syndrome, other congenital syndrome, chronic heart disease) that may make feeding and growth difficult (not to include HIV or TB)
- caretaker refusal of 2 blood draws
- ineligibility for outpatient therapy (ie, severe illness or anorexia requiring inpatient therapy)
- caretaker expresses plans to move away from local area of clinic, making followup difficult
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind Pilot Study of Polyunsaturated Fatty Acid-optimized Ready-to-use Therapeutic Food, Compared to Standard RUTF, in the Therapy of Severe Acute Malnutrition
To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as standard RUTF.
Read the detailed description
Since 2007, RUTF has been the recommended treatment for SAM. RUTF is not conducive to the growth of bacteria because of the low moisture content, does not require cooking, and has led to greater recovery rates than liquid milk formulations in direct comparisons. One expected benefit of the RUTF-P is improved outcomes due to the higher levels of essential fatty acids.
The essential fatty acid profile (i.e., the level of omega-3 and omega-6 fatty acids) of RUTF-P may have important implications for cognitive development of children, especially infants, with SAM who consume these foods as their sole dietary source for several weeks. In particular, an excess of omega-6 fatty acids (from sources such as peanut and corn oil) and a minimum of omega-3 fatty acids (from sources like flax) may fail to support optimal cognitive development and neural function.
In this prospective, double-blinded, randomized controlled clinical effectiveness trial, we will compare two RUTF products in the treatment of SAM to test the effects of the two different RUTF products on essential fatty acid status.
- Conditions
- Kwashiorkor, Marasmus
- Being tested
- RUTF, RUTF-P, Amoxicillin
- Keywords
- severe acute malnutrition, polyunsaturated fatty acids, ready-to-use therapeutic food
- Medical subject headings
- Kwashiorkor, Protein-Energy Malnutrition, Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUTFDietary supplement
Also called ready-to-use therapeutic food
RUTF-PDietary supplement
AmoxicillinDrug
| Study group | Role | What they receive |
|---|---|---|
| RUTF | Active comparator | Standard RUTF at a dose of 175 kcal/kg/d Receives: Dietary Supplement: RUTF; Drug: Amoxicillin |
| RUTF-P | Experimental | RUTF fortified with polyunsaturated fatty acids (PUFA) at a dose of 175 kcal/kg/d Receives: Dietary Supplement: RUTF-P; Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
DHA Level
Blood plasma docosahexaenoic acid (DHA) levels
Measured: 4 weeks
EPA Level
Blood plasma eicosapentaenoic acid (EPA) levels
Measured: 4 weeks
Secondary outcomes (4)
Recovery Rate
Proportion of children who recover from SAM
Measured: 12 weeks
Linear Growth
Changes in length
Measured: 12 weeks
Ponderal Growth
Changes in weight
Measured: 12 weeks
Growth
Changes in mid-upper-arm circumference
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KwashiorkorStudies 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
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malawi
- Responsible party
- Sponsor
- Investigators
- Mark J Manary, MD, Principal investigator, Washington University School of MedicineKenneth Maleta, MBBS PhD, Principal investigator, University of MalawiChrissie Thakwalakwa, Principal investigator, University of Malawi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053857
- Sponsor's protocol ID
- PUFA-RUTF Pilot
- Status last verified
- Sep 2014
- First submitted
- 31 Jan 2014
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Pilot Study of Polyunsaturated Fatty Acid-optimized Ready-to-use Therapeutic Food, Compared to Standard RUTF, in the Therapy of Severe Acute Malnutrition
- ClinicalTrials.gov ID
- NCT02053857
- Acronym / sponsor ID
- PUFA-RUTF Pilot
- Conditions
- Kwashiorkor, Marasmus
- Keywords
- severe acute malnutrition, polyunsaturated fatty acids, ready-to-use therapeutic food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Malawi
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Feb 2014 (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.
To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as standard RUTF.
Detailed description
Since 2007, RUTF has been the recommended treatment for SAM. RUTF is not conducive to the growth of bacteria because of the low moisture content, does not require cooking, and has led to greater recovery rates than liquid milk formulations in direct comparisons. One expected benefit of the RUTF-P is improved outcomes due to the higher levels of essential fatty acids.
The essential fatty acid profile (i.e., the level of omega-3 and omega-6 fatty acids) of RUTF-P may have important implications for cognitive development of children, especially infants, with SAM who consume these foods as their sole dietary source for several weeks. In particular, an excess of omega-6 fatty acids (from sources such as peanut and corn oil) and a minimum of omega-3 fatty acids (from sources like flax) may fail to support optimal cognitive development and neural function.
In this prospective, double-blinded, randomized controlled clinical effectiveness trial, we will compare two RUTF products in the treatment of SAM to test the effects of the two different RUTF products on essential fatty acid status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RUTF | Active comparator | Dietary Supplement: RUTF, Drug: AmoxicillinStandard RUTF at a dose of 175 kcal/kg/d |
| RUTF-P | Experimental | Dietary Supplement: RUTF-P, Drug: AmoxicillinRUTF fortified with polyunsaturated fatty acids (PUFA) at a dose of 175 kcal/kg/d |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- kwashiorkor and/or marasmus
- 6-59 months of age
- lives in local area near enrollment site
Key exclusion criteria (5 listed)
- recent (<4 months) therapeutic feeding for moderate or severe acute malnutrition
- chronic medical condition (eg, Down syndrome, other congenital syndrome, chronic heart disease) that may make feeding and growth difficult (not to include HIV or TB)
- caretaker refusal of 2 blood draws
- ineligibility for outpatient therapy (ie, severe illness or anorexia requiring inpatient therapy)
- caretaker expresses plans to move away from local area of clinic, making followup difficult
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 |
|---|---|---|
| RUTFAlso: ready-to-use therapeutic food | Dietary supplement | RUTF |
| RUTF-P | Dietary supplement | RUTF-P |
| Amoxicillin | Drug | RUTF, RUTF-P |
Primary outcome
DHA Level
Time frame: 4 weeks
Blood plasma docosahexaenoic acid (DHA) levels
EPA Level
Time frame: 4 weeks
Blood plasma eicosapentaenoic acid (EPA) levels
4 secondary outcomes
Recovery Rate
Time frame: 12 weeks
Linear Growth
Time frame: 12 weeks
Ponderal Growth
Time frame: 12 weeks
Growth
Time frame: 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 29 Sep 2014.
Related trials for Kwashiorkor
Active, not recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Active, not recruiting
Choline to Improve Malnutrition and Enhance Cognition
Severe Acute Malnutrition, Cognitive Impairment
Recruiting
Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA
Ulcerative Colitis (Disorder), Crohn Disease
Recruiting
The Effect of a Plant-based, Protein-dense Sauce on Essential Amino Acid Concentrations and Gut Fullness in Older Adults
Malnutrition Elderly, Protein Malnutrition
Not yet recruiting
Comparison of Clinical Outcomes According to High-protein Provision in Critically Ill Patients After Abdominal Surgery
Protein Malnutrition
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 principal investigator
Washington University School of Medicine
Kenneth Maleta, MBBS PhD principal investigator
University of Malawi
Chrissie Thakwalakwa principal investigator
University of Malawi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RUTF, RUTF-P and Amoxicillin in people with Kwashiorkor and Marasmus, 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 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 29 Sep 2014. 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?
DHA Level (time frame: 4 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?
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 29 Sep 2014.