Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers
Primary Purpose
Overweight, Hypovitaminosis D
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin D supplement
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
Eligibility Criteria
Inclusion Criteria:
- low serum vitamin D level <30ng/ml
- 25<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
Exclusion Criteria:
- Getting pregnant during the study
- Suffering from thyroid disorders and other diseases mentioned during the study
- Not taking supplements weekly
Sites / Locations
- 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Vitamin D3 supplement every week
Placebo every week
Outcomes
Primary Outcome Measures
Serum 25(OH)D
Fasting serum 25-hydroxyvitamin D level
Weight
Subject's weight wearing light clothing
Secondary Outcome Measures
Waist circumference
the measurement at the midpoint between the lowest rib and the iliac crest
Fat mass
Total body fat mass measured by Bioelectrical Impedance analysis method
Serum Fasting Glucose
Fasting serum glucose level
Serum total cholesterol
Fasting serum total cholesterol level
Serum triglyceride
Fasting serum triglyceride level Fasting serum triglyceride leve
Serum hsCRP
Fasting serum high sensitivity c-reactive protein level
Serum IL-6
Fasting serum Interleukin-6 level
Serum TNF-a
Fasting serum tumor necrosis factor alpha level
Serum PTH
Fasting serum parathyroid hormone level
Full Information
NCT ID
NCT05376865
First Posted
May 11, 2022
Last Updated
May 11, 2022
Sponsor
Tirang R. Neyestani, Ph.D.
Collaborators
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05376865
Brief Title
Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers
Official Title
The Interactive Effect of Vitamin D3 Supplementation and Vitamin D Receptor Polymorphisms on Obesity, Inflammatory and Metabolic Markers in Overweight Women With Hypovitaminosis D
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
December 29, 2021 (Actual)
Study Completion Date
February 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tirang R. Neyestani, Ph.D.
Collaborators
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
For the randomized controlled clinical trial (RCT), the first fifty eligible women were assigned to either the vitamin D or placebo group using the block randomization method. Each Vitamin D3 pearl (Zahravi Pharma Co, Tabriz, Iran) contained 50000 IU cholecalciferol and was administered weekly for 12 weeks according to guidelines for treating vitamin D deficiency. Placebo pearls (Zahravi Pharma Co, Tabriz, Iran) had the identical appearance, taste, and smell as the vitamin D pearls and could only be identified by the package code. The placebo pearls were administered similarly. To keep the study double-blinded, an assistant who was not involved in assessments managed the randomization and supplement assignment procedure. Participants were structured to hold their sun exposure and physical activity habits and not take any vitamin supplements during the study. They were also asked to inform the researcher before taking any new medications. All participants were provided with a moderately reduced diet (a reduction of 300 kcal per day) based on their basal weight. The nutrigenetic study investigated 75 eligible women (including the vitamin D group and the last fifty women who entered the study). The nutrigenetic study protocol was the same as that mentioned above for the vitamin D group in the RCT. Compliance was ensured by weekly text messages and voice calls to remind the users of the supplement on the given day. In addition, the supplement and placebo pearls were presented in two visits; once at the baseline visit and then after six weeks. Pearls packs were collected from each subject (at week 6 and week 12) to check if all the pearls were consumed as recommended.
During the first and last visits, anthropometric and laboratory assessments were performed for all subjects. The primary outcomes are improving anthropometric, inflammatory, and metabolic markers of overweight women with hypovitaminosis D.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Hypovitaminosis D
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Vitamin D3 supplement every week
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo every week
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D supplement
Intervention Description
The intervention group receives 50000 IU of vitamin D every week as vitamin D supplements for 12 weeks, provided monthly.
Primary Outcome Measure Information:
Title
Serum 25(OH)D
Description
Fasting serum 25-hydroxyvitamin D level
Time Frame
12 weeks
Title
Weight
Description
Subject's weight wearing light clothing
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Waist circumference
Description
the measurement at the midpoint between the lowest rib and the iliac crest
Time Frame
12 weeks
Title
Fat mass
Description
Total body fat mass measured by Bioelectrical Impedance analysis method
Time Frame
12 weeks
Title
Serum Fasting Glucose
Description
Fasting serum glucose level
Time Frame
12 weeks
Title
Serum total cholesterol
Description
Fasting serum total cholesterol level
Time Frame
12 weeks
Title
Serum triglyceride
Description
Fasting serum triglyceride level Fasting serum triglyceride leve
Time Frame
12 weeks
Title
Serum hsCRP
Description
Fasting serum high sensitivity c-reactive protein level
Time Frame
12 weeks
Title
Serum IL-6
Description
Fasting serum Interleukin-6 level
Time Frame
12 weeks
Title
Serum TNF-a
Description
Fasting serum tumor necrosis factor alpha level
Time Frame
12 weeks
Title
Serum PTH
Description
Fasting serum parathyroid hormone level
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
low serum vitamin D level <30ng/ml
25<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
Exclusion Criteria:
Getting pregnant during the study
Suffering from thyroid disorders and other diseases mentioned during the study
Not taking supplements weekly
Facility Information:
Facility Name
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
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers
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