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

The Interactive Effect of Vitamin D3 Supplementation and Vitamin D Receptor Polymorphisms on Obesity, Inflammatory and Metabolic Markers in Overweight Women With Hypovitaminosis D

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Hypovitaminosis D
• Intervention / Treatment: Dietary supplement: Vitamin D supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Vitamin D3 supplement every week	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.
PLACEBO_COMPARATOR: Control; Placebo every week	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum 25(OH)D	Fasting serum 25-hydroxyvitamin D level	12 weeks
Weight	Subject's weight wearing light clothing	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	the measurement at the midpoint between the lowest rib and the iliac crest	12 weeks
Fat mass	Total body fat mass measured by Bioelectrical Impedance analysis method	12 weeks
Serum Fasting Glucose	Fasting serum glucose level	12 weeks
Serum total cholesterol	Fasting serum total cholesterol level	12 weeks
Serum triglyceride	Fasting serum triglyceride level Fasting serum triglyceride leve	12 weeks
Serum hsCRP	Fasting serum high sensitivity c-reactive protein level	12 weeks
Serum IL-6	Fasting serum Interleukin-6 level	12 weeks
Serum TNF-a	Fasting serum tumor necrosis factor alpha level	12 weeks
Serum PTH	Fasting serum parathyroid hormone level	12 weeks

Collaborators and Investigators

• Sponsor: Tirang R. Neyestani, Ph.D.
• Collaborators: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 29, 2021
• Primary Completion (ACTUAL): December 29, 2021
• Study Completion (ACTUAL): February 20, 2022

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (ACTUAL): May 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Body Weight; Musculoskeletal Diseases; Deficiency Diseases; Malnutrition; Bone Diseases; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Vitamin D Deficiency; Overweight; Rickets; Avitaminosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 26

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No