Emollient Therapy for Severe Acute Malnutrition

Not Recruiting

Trial ID: NCT02616289


The investigators hypothesize that the absorption of topically applied EFA-containing emollient (SSO) into the skin and thence into the bloodstream in children with SAM will improve skin barrier function and accelerate weight gain and clinical rehabilitation beyond that possible through normal standard-of-care

Official Title

Topical Emollient Therapy in the Management of Severe Acute Malnutrition: A Randomized Controlled Clinical Trial in Bangladesh

Stanford Investigator(s)

Marc L. Melcher
Marc L. Melcher

Professor of Surgery (Abdominal Transplantation)

Frederick Mihm, M.D.
Frederick Mihm, M.D.

Professor of Anesthesiology, Perioperative and Pain Medicine (ICU)


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

   - 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

   - The child is in care (no longer looked after by their parent or legal guardian)

   - Participation in another study


other: Topical emollient (Sun Flower seed oil)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305