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

NCT ID: NCT05376865

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-29
• Study Completion Date: 2022-02-20

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.

Conditions

Overweight; Hypovitaminosis D

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

Vitamin D3 supplement every week

Group Type: EXPERIMENTAL

Vitamin D supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Control

Placebo every week

Group Type: PLACEBO_COMPARATOR

Vitamin D supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Vitamin D supplement

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: collaborator

Tirang R. Neyestani, Ph.D.

OTHER

Sponsor Role: lead

Responsible Party

Tirang R. Neyestani, Ph.D.

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Countries

Iran

Other Identifiers

26

Identifier Type: -

Identifier Source: org_study_id