Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers
The Interactive Effect of Vitamin D3 Supplementation and Vitamin D Receptor Polymorphisms on Obesity, Inflammatory and Metabolic Markers in Overweight Women With Hypovitaminosis D
1 other identifier
interventional
46
1 country
1
Brief Summary
46 eligible overweight women with hypovitaminosis D are assigned to either vitamin D or control group using block randomization method. Vitamin D3 pearl (Zahravi Pharma Co, Tabriz, Iran) containing 50000 IU cholecalciferol or placebo are administered weekly for 12 weeks. Participants in both groups are structured to hold their sun exposure and physical activity habits and not take any vitamin supplements during the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2022
CompletedFirst Submitted
Initial submission to the registry
May 11, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2022
CompletedMay 17, 2022
May 1, 2022
3 months
May 11, 2022
May 11, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Serum 25(OH)D
Fasting serum 25-hydroxyvitamin D level
12 weeks
Weight
Subject's weight wearing light clothing
12 weeks
Secondary Outcomes (9)
Waist circumference
12 weeks
Fat mass
12 weeks
Serum Fasting Glucose
12 weeks
Serum total cholesterol
12 weeks
Serum triglyceride
12 weeks
- +4 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALVitamin D3 supplement every week
Control
PLACEBO COMPARATORPlacebo every week
Interventions
The intervention group receives 50000 IU of vitamin D every week as vitamin D supplements for 12 weeks, provided monthly.
Eligibility Criteria
You may qualify if:
- low serum vitamin D level \<30ng/ml
- \<BMI\<30 kg/m2
- Age: 20-50
- Free of chronic diseased such as cancer, diabetes, cardiovascular disease, renal diseases, gastrointestinal diseases, no multivitamin supplement intake, no change in weight in the last 3 months
You may not qualify if:
- Getting pregnant during the study
- Suffering from thyroid disorders and other diseases mentioned during the study
- Not taking supplements weekly
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Tehran, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
May 11, 2022
First Posted
May 17, 2022
Study Start
September 29, 2021
Primary Completion
December 29, 2021
Study Completion
February 20, 2022
Last Updated
May 17, 2022
Record last verified: 2022-05