Malnutrition Clinical Trial
Official title:
Topical Emollient Therapy in the Management of Severe Acute Malnutrition: A Randomized Controlled Clinical Trial in Bangladesh
NCT number | NCT02616289 |
Other study ID # | PR-15101 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | December 31, 2019 |
Verified date | December 2019 |
Source | International Centre for Diarrhoeal Disease Research, Bangladesh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 212 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 24 Months |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Dhaka Hospital, icddr,b | Dhaka |
Lead Sponsor | Collaborator |
---|---|
International Centre for Diarrhoeal Disease Research, Bangladesh | GlaxoSmithKline, Stanford University |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes of body weight | Body weight will be measured after 10 days of intervention | Baseline and 10th day | |
Secondary | 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. | through study completion, an average of 5 days | |
Secondary | Reduction of rate of nosocomial infections between cases and controls | Reduction of rate of nosocomial infections between cases and controls | through study completion, an average of 10 days | |
Secondary | Reduction in TEWL | Reduction in trans-epidermal water loss (TEWL) which will be measured by Tewameter | baseline and 10th day | |
Secondary | 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. | Baseline and 10th day | |
Secondary | 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. | Baseline and 10th day | |
Secondary | 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. | Baseline and 10th day | |
Secondary | 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. | Baseline and 10th day |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT03268902 -
Early Life Interventions for Childhood Growth and Development In Tanzania
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
Completed |
NCT04608656 -
Livestock for Health Project
|
N/A | |
Completed |
NCT06009198 -
Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan
|
N/A | |
Recruiting |
NCT05417672 -
Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
|
||
Recruiting |
NCT05257980 -
Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial
|
N/A | |
Completed |
NCT05015647 -
Low Protein Diet in CKD Patients at Risk of Malnutrition
|
N/A | |
Completed |
NCT03628196 -
A Nutrition-Focused QIP in Outpatient Clinics
|
||
Enrolling by invitation |
NCT04675229 -
Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
|
||
Recruiting |
NCT04627376 -
Multimodal Program for Cancer Related Cachexia Prevention
|
N/A | |
Not yet recruiting |
NCT06047054 -
Incidence Rate and Risk Factors of Malnutrition in ICU
|
||
Not yet recruiting |
NCT05860556 -
Sustainable Eating Pattern to Limit Malnutrition in Older Adults
|
||
Not yet recruiting |
NCT04183075 -
Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture
|
N/A | |
Not yet recruiting |
NCT04398836 -
Preoperative Nutrition for Crohn's Disease Patients
|
Phase 3 | |
Not yet recruiting |
NCT03150927 -
Clinical Study of Novel Probiotic Microbial Compositeā¢ to Treat Undernourished Young Children
|
N/A | |
Recruiting |
NCT03408067 -
Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients
|
N/A | |
Recruiting |
NCT02833740 -
Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition
|
N/A | |
Completed |
NCT02938234 -
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake
|
N/A | |
Completed |
NCT02938247 -
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake
|
N/A |