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Emollient Therapy for Severe Acute Malnutrition

NCT02616289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2020-01-09

No results posted yet for this study

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

Interventions

OTHER

Topical emollient (Sun Flower seed oil)

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.

Sponsors & Collaborators

Principal Investigators

  • K M Shahunja, MBBS · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Bangladesh

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02616289 on ClinicalTrials.gov