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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02053857 |
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Date of registration:
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31/01/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition
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Scientific title:
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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 |
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Date of first enrolment:
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February 2014 |
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Target sample size:
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141 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02053857 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Malawi
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Contacts
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Name:
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Mark J Manary, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington University School of Medicine |
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Name:
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Chrissie Thakwalakwa |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Malawi |
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Name:
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Kenneth Maleta, MBBS PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Malawi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- kwashiorkor and/or marasmus
- 6-59 months of age
- lives in local area near enrollment site
Exclusion Criteria:
- 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
Age minimum:
6 Months
Age maximum:
59 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kwashiorkor
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Marasmus
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Intervention(s)
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Dietary Supplement: RUTF
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Dietary Supplement: RUTF-P
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Drug: Amoxicillin
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Primary Outcome(s)
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EPA Level
[Time Frame: 4 weeks]
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DHA Level
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Recovery Rate
[Time Frame: 12 weeks]
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Ponderal Growth
[Time Frame: 12 weeks]
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Linear Growth
[Time Frame: 12 weeks]
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Growth
[Time Frame: 12 weeks]
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Secondary ID(s)
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PUFA-RUTF Pilot
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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