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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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12 December 2020 |
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Main ID: |
NCT02616289 |
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Date of registration:
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18/11/2015 |
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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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Emollient Therapy for Severe Acute Malnutrition
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Scientific title:
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Topical Emollient Therapy in the Management of Severe Acute Malnutrition: A Randomized Controlled Clinical Trial in Bangladesh |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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212 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02616289 |
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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. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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K M Shahunja, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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International Centre for Diarrhoeal Disease Research, Bangladesh |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Parent or legal guardian is willing and able to provide written informed consent for
the subject to take part in the trial and comply with an inpatient stay of at least 10
days.
- Children aged 2-24 months inclusive diagnosed with SAM (weight-for-length Z score <-3
or bilateral pedal edema) admitted in the Dhaka Hospital of icddr,b, Dhaka, Bangladesh
- Willing to suspend usual home skin care treatments for the duration of study
Exclusion Criteria:
- Consent refusal
- Life threatening health conditions such as septic shock and altered consciousness on
admission; congenital problems (congenital heart disease or known metabolic disorders,
chromosomal abnormalities, renal failure, etc.); any known chronic disease including
tuberculosis, HIV infection
- History of drug or other allergy or any condition that may complicate the
interpretation of safety or efficacy such as dermatitis which, in the opinion of the
investigator, contraindicates participation in the trial, or know hypersensitivity to
SSO
- The child is in care (no longer looked after by their parent or legal guardian)
- Participation in another study
Age minimum:
2 Months
Age maximum:
24 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malnutrition in Children
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Malnutrition
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Child Malnutrition
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Intervention(s)
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Other: Topical emollient (Sun Flower seed oil)
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Primary Outcome(s)
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changes of body weight
[Time Frame: Baseline and 10th day]
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Secondary Outcome(s)
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Serum CRP level
[Time Frame: Baseline and 10th day]
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Skin condition changes
[Time Frame: Baseline and 10th day]
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Reduction in TEWL
[Time Frame: baseline and 10th day]
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Serum essential fatty acids (EFAs) level
[Time Frame: Baseline and 10th day]
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Time to discharge from acute illnesses
[Time Frame: through study completion, an average of 5 days]
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Reduction of rate of nosocomial infections between cases and controls
[Time Frame: through study completion, an average of 10 days]
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Serum Cytokines level
[Time Frame: Baseline and 10th day]
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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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