Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers
Condition: Overweight; Hypovitaminosis D
MeSH terms: Rickets; Overweight; Avitaminosis; Vitamin D Deficiency
Study type: Interventional

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.
    

Intervention name(s): Vitamin D supplement
Intervention type(s): Dietary Supplement
Intervention description(s): The intervention group receives 50000 IU of vitamin D every week as vitamin D supplements for 12 weeks, provided monthly.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment