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

Overweight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376865
• Other study ID #: 26
• Status: Completed
• Phase: N/A
• Start date: September 29, 2021
• Est. completion date: February 20, 2022

Study information

• Verified date: May 2022
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 20, 2022
• Est. primary completion date: December 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Avitaminosis
• Hypovitaminosis D
• Overweight
• Rickets
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D supplement
The intervention group receives 50000 IU of vitamin D every week as vitamin D supplements for 12 weeks, provided monthly.

Locations

Country	Name	City	State
Iran, Islamic Republic of	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

Sponsors (2)

Lead Sponsor	Collaborator
Tirang R. Neyestani, Ph.D.	Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25(OH)D	Fasting serum 25-hydroxyvitamin D level	12 weeks
Primary	Weight	Subject's weight wearing light clothing	12 weeks
Secondary	Waist circumference	the measurement at the midpoint between the lowest rib and the iliac crest	12 weeks
Secondary	Fat mass	Total body fat mass measured by Bioelectrical Impedance analysis method	12 weeks
Secondary	Serum Fasting Glucose	Fasting serum glucose level	12 weeks
Secondary	Serum total cholesterol	Fasting serum total cholesterol level	12 weeks
Secondary	Serum triglyceride	Fasting serum triglyceride level Fasting serum triglyceride leve	12 weeks
Secondary	Serum hsCRP	Fasting serum high sensitivity c-reactive protein level	12 weeks
Secondary	Serum IL-6	Fasting serum Interleukin-6 level	12 weeks
Secondary	Serum TNF-a	Fasting serum tumor necrosis factor alpha level	12 weeks
Secondary	Serum PTH	Fasting serum parathyroid hormone level	12 weeks