Emollient Therapy for Severe Acute Malnutrition

NCT02616289 | Completed DMC

• 1 other identifier: PR-15101
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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

Conditions

Child Malnutrition; Malnutrition in Children; Malnutrition

Outcome Measures

Primary Outcomes (1)

• changes of body weight

  Body weight will be measured after 10 days of intervention

  Baseline and 10th day

Secondary Outcomes (7)

• Time to discharge from acute illnesses

  through study completion, an average of 5 days

• Reduction of rate of nosocomial infections between cases and controls

  through study completion, an average of 10 days

• Reduction in TEWL

  baseline and 10th day

• Serum CRP level

  Baseline and 10th day

• Serum Cytokines level

  Baseline and 10th day

Study Arms (2)

Emollient

EXPERIMENTAL

Topical emollient (Sun Flower seed oil) in addition to routine standard of care for severe acute malnutrition.

Other: Topical emollient (Sun Flower seed oil)

Control

NO INTERVENTION

Routine Standard of care only for severe acute malnutrition.

Interventions

Topical emollient (Sun Flower seed oil) OTHER

3 g of oil per kg of infant's weight at study entry of Sunflower Seed oil (SSO) will be applied three times per day at regularly spaced intervals (8-hour intervals) for 10 days. Oil will not be applied to the face (to avoid the possibility of any accidental aspiration or ingestion), ears or under the hairline. Care will be taken to not injure the skin during the massage treatment. The child's anal area will be washed prior to application to avoid the spread fecal flora from the anal region (to which the oil will be applied to last). Prior to bathing the child a minimum of 3-4 hours should have elapsed following the application of the SSO. The amount of oil required will be calculated based on the child's weight and the required amount weighed out each time.

Emollient

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• GlaxoSmithKline: collaborator
• Stanford University: collaborator

Study Sites (1)

Dhaka Hospital, icddr,b

Dhaka, 1212, Bangladesh

Location

Related Publications (3)

• 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.

  PMID: 34386216 DERIVED

• 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.

  PMID: 34092255 DERIVED

• 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.

  PMID: 32509290 DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders; Malnutrition

Interventions

Emollients

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• K M Shahunja, MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical Trial in two treatment arms

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 26, 2015
• Study Start: January 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 9, 2020

Record last verified: 2019-12

Locations

BA (1)