Clinical trial NCT02616289: Emollient Therapy for Severe Acute Malnutrition
Official title: Topical Emollient Therapy in the Management of Severe Acute Malnutrition: A Randomized Controlled Clinical Trial in Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Malnutrition
Malnutrition in Children
Malnutrition
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: Stanford University
First posted: 2015-11-26
Enrollment: 212
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical Trial in two treatment arms
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: A child with SAM, in addition to wasting will often present with infection, hypothermia, dehydration and electrolyte imbalance - complications attributable, at least in part, to compromised skin barrier function. Essential fatty acid (EFA)-containing emollients such as sunflower seed oil (SSO) have been shown to augment skin barrier function, reduce transepidermal water loss (TEWL) and risk of bloodstream infection and mortality, and promote weight gain in preterm infants. Recent research from rural Bangladesh showed very low levels of EFAs in young children in the general population. It is believed that EFA levels will be further depleted in children with SAM. So the investigators aim to demonstrate the feasibility of topical applications of SSO to children with SAM, and to measure clinical impact of emollient therapy with SSO on skin barrier function, skin condition, EFA levels in blood, weight gain, co-morbidities (e.g., pneumonia, sepsis), and time to complete acute rehabilitation from SAM, in addition to the benefits of normal standard-of-care.

Eligibility criteria: 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

Primary outcomes:
measure: changes of body weight
timeFrame: Baseline and 10th day
Secondary outcomes:
measure: Time to discharge from acute illnesses
timeFrame: through study completion, an average of 5 days
measure: Reduction of rate of nosocomial infections between cases and controls
timeFrame: through study completion, an average of 10 days
measure: Reduction in TEWL
timeFrame: baseline and 10th day
measure: Serum CRP level
timeFrame: Baseline and 10th day
measure: Serum Cytokines level
timeFrame: Baseline and 10th day
measure: Serum essential fatty acids (EFAs) level
timeFrame: Baseline and 10th day
measure: Skin condition changes
timeFrame: Baseline and 10th day
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Dhaka Hospital, icddr,b
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: K M Shahunja, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fischer N, Darmstadt GL, Shahunja KM, Crowther JM, Kendall L, Gibson RA, Ahmed T, Relman DA. Topical emollient therapy with sunflower seed oil alters the skin microbiota of young children with severe acute malnutrition in Bangladesh: A randomised, controlled study. J Glob Health. 2021 Jul 17;11:04047. doi: 10.7189/jogh.11.04047. eCollection 2021.
citation: Shahunja KM, Sevin DC, Kendall L, Ahmed T, Hossain MI, Mahfuz M, Zhu X, Singh K, Singh S, Crowther JM, Gibson RA, Darmstadt GL. Effect of topical applications of sunflower seed oil on systemic fatty acid levels in under-two children under rehabilitation for severe acute malnutrition in Bangladesh: a randomized controlled trial. Nutr J. 2021 Jun 6;20(1):51. doi: 10.1186/s12937-021-00707-3.
citation: Shahunja KM, Ahmed T, Hossain MI, Mahfuz M, Kendall L, Zhu X, Singh K, Crowther JM, Singh S, Gibson RA, Darmstadt GL. Topical emollient therapy in the management of severe acute malnutrition in children under two: A randomized controlled clinical trial in Bangladesh. J Glob Health. 2020 Jun;10(1):010414. doi: 10.7189/jogh.10.010414.