Clinical trial NCT05376865: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Hypovitaminosis D
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2022-05-17
Enrollment: 46
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Serum 25(OH)D
timeFrame: 12 weeks
measure: Weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Waist circumference
timeFrame: 12 weeks
measure: Fat mass
timeFrame: 12 weeks
measure: Serum Fasting Glucose
timeFrame: 12 weeks
measure: Serum total cholesterol
timeFrame: 12 weeks
measure: Serum triglyceride
timeFrame: 12 weeks
measure: Serum hsCRP
timeFrame: 12 weeks
measure: Serum IL-6
timeFrame: 12 weeks
measure: Serum TNF-a
timeFrame: 12 weeks
measure: Serum PTH
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: 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
Study officials:
References: