Home » Trials » SLCTR/2015/017
Effects of vitamin D supplementation on metabolic derangements among Obese Children: A Randomized Clinical Trial
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SLCTR Registration Number
SLCTR/2015/017
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effects of vitamin D supplementation on metabolic derangements among Obese Children: A Randomized Clinical Trial
Public Title of Trial
Effects of Vitamin D supplementation on childhood obesity
Disease or Health Condition(s) Studied
Childhood Obesity
Scientific Acronym
None
Public Acronym
None
Brief title
Prevalence and effects of Vitamin D deficiency in childhood obesity and effects of supplementation
Universal Trial Number
U1111-1162-7629
Any other number(s) assigned to the trial and issuing authority
ERC Colombo Ref: EC-15-010
What is the research question being addressed?
What is the effect of vitamin D supplementation on selected metabolic components in obese children?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
The study will be conducted in two stages.
Obese children attending the obesity clinic at the Lady Ridgeway Hospital and residing in Colombo municipal area will be selected for stage I of the study. Following clinical as well as metabolic screening with assessment of vitamin D levels, those who are diagnosed to have vitamin D deficiency will be recruited into stage II of the study.
The recruited children will be randomized into three arms.
Arm I: Structured diet + Physical activity+ Vitamin D2 treatment dose of 50,000 IU weekly (high dose arm)
Arm II: Structured diet + Physical activity + Vitamin D2 supplementation dose of 3000 IU weekly (low dose arm).
Arm III: Structured diet + Physical activity + placebo weekly
All three arms will receive treatment for a total of 24 weeks. All tablets will be prepared and packaged in an identical manner.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ At baseline and at the end of 24 weeks of intervention ] |
Secondary outcome(s)
|
1.
|
[ 3 months after commencement of supplementation ] |
Target number/sample size
75 (25 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-09-14
Anticipated end date
2016-08-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
National Science Foundation (grant no RG/2015/HS/09)
Regulatory approvals
Status
Approved
Date of Approval
2015-04-23
Approval number
EC-15-010
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
V.P. Wickramasinghe
Professor in Paediatrics
Department of Paediatrics, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo 00800
+94 112 688748
+94 777766595
+94 112 691581
pujithaw@yahoo.com
Contact Person for Public Queries
V.P. Wickramasinghe
Professor in Paediatrics
Department of Paediatrics, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo 00800
+94 112 688748
+94 777766595
+94 112 691581
pujithaw@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
