Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Interactive Effect of Vitamin D3 Supplementation and Vitamin D Receptor Polymorphisms on Obesity, Inflammatory and Metabolic Markers in Overweight Women With Hypovitaminosis D

Conditions
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Overweight, Hypovitaminosis D

Intervention / Treatment
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* Dietary Supplement: Vitamin D supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Vitamin D3 supplement every week | Dietary Supplement: Vitamin D supplement<br>* The intervention group receives 50000 IU of vitamin D every week as vitamin D supplements for 12 weeks, provided monthly.<br>|
| Placebo Comparator: Control<br>Placebo every week | Dietary Supplement: Vitamin D supplement<br>* The intervention group receives 50000 IU of vitamin D every week as vitamin D supplements for 12 weeks, provided monthly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25(OH)D | Fasting serum 25-hydroxyvitamin D level | 12 weeks | 
| Weight | Subject's weight wearing light clothing | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | the measurement at the midpoint between the lowest rib and the iliac crest | 12 weeks | 
| Fat mass | Total body fat mass measured by Bioelectrical Impedance analysis method | 12 weeks | 
| Serum Fasting Glucose | Fasting serum glucose level | 12 weeks | 
| Serum total cholesterol | Fasting serum total cholesterol level | 12 weeks | 
| Serum triglyceride | Fasting serum triglyceride level Fasting serum triglyceride leve | 12 weeks | 
| Serum hsCRP | Fasting serum high sensitivity c-reactive protein level | 12 weeks | 
| Serum IL-6 | Fasting serum Interleukin-6 level | 12 weeks | 
| Serum TNF-a | Fasting serum tumor necrosis factor alpha level | 12 weeks | 
| Serum PTH | Fasting serum parathyroid hormone level | 12 weeks |