Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers
- Conditions
- OverweightHypovitaminosis D
- Interventions
- Dietary Supplement: Vitamin D supplement
- Registration Number
- NCT05376865
- Lead Sponsor
- Tirang R. Neyestani, Ph.D.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 46
- 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
- Getting pregnant during the study
- Suffering from thyroid disorders and other diseases mentioned during the study
- Not taking supplements weekly
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Vitamin D supplement Vitamin D3 supplement every week Control Vitamin D supplement Placebo every week
- Primary Outcome Measures
Name Time Method Serum 25(OH)D 12 weeks Fasting serum 25-hydroxyvitamin D level
Weight 12 weeks Subject's weight wearing light clothing
- Secondary Outcome Measures
Name Time Method Serum triglyceride 12 weeks Fasting serum triglyceride level Fasting serum triglyceride leve
Serum hsCRP 12 weeks Fasting serum high sensitivity c-reactive protein level
Serum IL-6 12 weeks Fasting serum Interleukin-6 level
Serum total cholesterol 12 weeks Fasting serum total cholesterol level
Fat mass 12 weeks Total body fat mass measured by Bioelectrical Impedance analysis method
Serum Fasting Glucose 12 weeks Fasting serum glucose level
Serum TNF-a 12 weeks Fasting serum tumor necrosis factor alpha level
Serum PTH 12 weeks Fasting serum parathyroid hormone level
Waist circumference 12 weeks the measurement at the midpoint between the lowest rib and the iliac crest
Trial Locations
- Locations (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, Islamic Republic of