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OpenTrials
Completed

NCT Number: NCT05376865

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

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.

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Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamin D supplement

Dietary Supplement

The intervention group receives 50000 IU of vitamin D every week as vitamin D supplements for 12 weeks, provided monthly.

Primary outcomes

  1. Serum 25(OH)D

    Time frame: 12 weeks

    Fasting serum 25-hydroxyvitamin D level

  2. Weight

    Time frame: 12 weeks

    Subject's weight wearing light clothing

Secondary outcomes

  1. Waist circumference

    Time frame: 12 weeks

    the measurement at the midpoint between the lowest rib and the iliac crest

  2. Fat mass

    Time frame: 12 weeks

    Total body fat mass measured by Bioelectrical Impedance analysis method

  3. Serum Fasting Glucose

    Time frame: 12 weeks

    Fasting serum glucose level

  4. Serum total cholesterol

    Time frame: 12 weeks

    Fasting serum total cholesterol level

  5. Serum triglyceride

    Time frame: 12 weeks

    Fasting serum triglyceride level Fasting serum triglyceride leve

  6. Serum hsCRP

    Time frame: 12 weeks

    Fasting serum high sensitivity c-reactive protein level

  7. Serum IL-6

    Time frame: 12 weeks

    Fasting serum Interleukin-6 level

  8. Serum TNF-a

    Time frame: 12 weeks

    Fasting serum tumor necrosis factor alpha level

  9. Serum PTH

    Time frame: 12 weeks

    Fasting serum parathyroid hormone level

Sponsors and collaborators

Lead sponsor

Tirang R. Neyestani, Ph.D.

Other

Collaborators

  • Shahid Beheshti University of Medical Sciences

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 17, 2022
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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