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Emollient Therapy for Severe Acute Malnutrition

Primary Purpose

Child Malnutrition, Malnutrition in Children, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Topical emollient (Sun Flower seed oil)
Sponsored by
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Malnutrition

Eligibility Criteria

2 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dhaka Hospital, icddr,b

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Emollient

Control

Arm Description

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

Routine Standard of care only for severe acute malnutrition.

Outcomes

Primary Outcome Measures

changes of body weight
Body weight will be measured after 10 days of intervention

Secondary Outcome Measures

Time to discharge from acute illnesses
Time to discharge from acute illnesses like, diarrhea, pneumonia, enteric fever etc which usually associated with severe acute malnutrition.
Reduction of rate of nosocomial infections between cases and controls
Reduction of rate of nosocomial infections between cases and controls
Reduction in TEWL
Reduction in trans-epidermal water loss (TEWL) which will be measured by Tewameter
Serum CRP level
Serum CRP level will be assessed before and after the intervention to know the potential impact of the intervention on this change.
Serum Cytokines level
Serum Cytokines (inflammatory) level will be assessed before and after the intervention to know the potential impact of the intervention on these changes.
Serum essential fatty acids (EFAs) level
Serum EFAs level will be assessed before and after the intervention to know the potential impact of the intervention on these changes.
Skin condition changes
Clinical improvement of skin conditions will be measured by a predefined skin scoring system where the value of the score increase proportionately (score '0' in normal skin condition) with the skin changes. Investigators will compare the score with baseline after intervention among the groups.

Full Information

First Posted
November 18, 2015
Last Updated
January 7, 2020
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
GlaxoSmithKline, Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02616289
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
GlaxoSmithKline, Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Malnutrition, Malnutrition in Children, Malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical Trial in two treatment arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emollient
Arm Type
Experimental
Arm Description
Topical emollient (Sun Flower seed oil) in addition to routine standard of care for severe acute malnutrition.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine Standard of care only for severe acute malnutrition.
Intervention Type
Other
Intervention Name(s)
Topical emollient (Sun Flower seed oil)
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes of body weight
Description
Body weight will be measured after 10 days of intervention
Time Frame
Baseline and 10th day
Secondary Outcome Measure Information:
Title
Time to discharge from acute illnesses
Description
Time to discharge from acute illnesses like, diarrhea, pneumonia, enteric fever etc which usually associated with severe acute malnutrition.
Time Frame
through study completion, an average of 5 days
Title
Reduction of rate of nosocomial infections between cases and controls
Description
Reduction of rate of nosocomial infections between cases and controls
Time Frame
through study completion, an average of 10 days
Title
Reduction in TEWL
Description
Reduction in trans-epidermal water loss (TEWL) which will be measured by Tewameter
Time Frame
baseline and 10th day
Title
Serum CRP level
Description
Serum CRP level will be assessed before and after the intervention to know the potential impact of the intervention on this change.
Time Frame
Baseline and 10th day
Title
Serum Cytokines level
Description
Serum Cytokines (inflammatory) level will be assessed before and after the intervention to know the potential impact of the intervention on these changes.
Time Frame
Baseline and 10th day
Title
Serum essential fatty acids (EFAs) level
Description
Serum EFAs level will be assessed before and after the intervention to know the potential impact of the intervention on these changes.
Time Frame
Baseline and 10th day
Title
Skin condition changes
Description
Clinical improvement of skin conditions will be measured by a predefined skin scoring system where the value of the score increase proportionately (score '0' in normal skin condition) with the skin changes. Investigators will compare the score with baseline after intervention among the groups.
Time Frame
Baseline and 10th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K M Shahunja, MBBS
Organizational Affiliation
International Centre for Diarrhoeal Disease Research, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dhaka Hospital, icddr,b
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh

12. IPD Sharing Statement

Citations:
PubMed Identifier
34386216
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.
Results Reference
derived
PubMed Identifier
34092255
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.
Results Reference
derived
PubMed Identifier
32509290
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.
Results Reference
derived

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Emollient Therapy for Severe Acute Malnutrition

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