Child MalnutritionNCT02616289
Emollient Therapy for Severe Acute Malnutrition
A study testing Topical emollient (Sun Flower seed oil) in people with Child Malnutrition and Malnutrition in Children, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial 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 Read more about this study
- Who is it for?
- Ages 2 to 24 months
- Conditions the study is for
- Child Malnutrition, Malnutrition in Children, Malnutrition
- What is being tested?
- Topical emollient (Sun Flower seed oil)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteBangladesh
- Study dates
- Jan 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Emollient Therapy in the Management of Severe Acute Malnutrition: A Randomized Controlled Clinical Trial in Bangladesh
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
Read the 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.
- Conditions
- Child Malnutrition, Malnutrition in Children, Malnutrition
- Being tested
- Topical emollient (Sun Flower seed oil)
- Medical subject headings
- Child Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Emollient | Experimental | Topical emollient (Sun Flower seed oil) in addition to routine standard of care for severe acute malnutrition. Receives: Other: Topical emollient (Sun Flower seed oil) |
| Control | No intervention | Routine Standard of care only for severe acute malnutrition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of body weight
Body weight will be measured after 10 days of intervention
Measured: Baseline and 10th day
Secondary outcomes (7)
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.
Measured: through study completion, an average of 5 days
Reduction of rate of nosocomial infections between cases and controls
Reduction of rate of nosocomial infections between cases and controls
Measured: through study completion, an average of 10 days
Reduction in TEWL
Reduction in trans-epidermal water loss (TEWL) which will be measured by Tewameter
Measured: baseline and 10th day
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.
Measured: Baseline and 10th day
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.
Measured: Baseline and 10th day
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.
Measured: Baseline and 10th day
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.
Measured: Baseline and 10th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startJan 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical Trial in two treatment arms
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Stanford University
- Responsible party
- Sponsor
- Investigators
- K M Shahunja, MBBS, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616289
- Sponsor's protocol ID
- PR-15101
- Status last verified
- Dec 2019
- First submitted
- 18 Nov 2015
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34386216Shahunja 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.
PubMed 34092255Shahunja 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.
PubMed 32509290
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Emollient Therapy in the Management of Severe Acute Malnutrition: A Randomized Controlled Clinical Trial in Bangladesh
- ClinicalTrials.gov ID
- NCT02616289
- Acronym / sponsor ID
- PR-15101
- Conditions
- Child Malnutrition, Malnutrition in Children, Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Stanford University
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical Trial in two treatment arms
| Arm | Type | Receives |
|---|---|---|
| Emollient | Experimental | Other: Topical emollient (Sun Flower seed oil)Topical emollient (Sun Flower seed oil) in addition to routine standard of care for severe acute malnutrition. |
| Control | No intervention | –Routine Standard of care only for severe acute malnutrition. |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Emollient |
Primary outcome
changes of body weight
Time frame: Baseline and 10th day
Body weight will be measured after 10 days of intervention
7 secondary outcomes
Time to discharge from acute illnesses
Time frame: through study completion, an average of 5 days
Reduction of rate of nosocomial infections between cases and controls
Time frame: through study completion, an average of 10 days
Reduction in TEWL
Time frame: baseline and 10th day
Serum CRP level
Time frame: Baseline and 10th day
Serum Cytokines level
Time frame: Baseline and 10th day
Serum essential fatty acids (EFAs) level
Time frame: Baseline and 10th day
Skin condition changes
Time frame: Baseline and 10th day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Derived from this study: PubMed 34386216Fischer 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.
- Derived from this study: PubMed 34092255Shahunja 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.
- Derived from this study: PubMed 32509290Shahunja 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K M Shahunja, MBBS principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical emollient (Sun Flower seed oil) in people with Child Malnutrition and Malnutrition in Children, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of body weight (time frame: Baseline and 10th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02616289, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.