Vitamin D and Adipose Tissue: a Complex Relationship

Completed

• Conditions: Hypovitaminosis D

• Registration Number: NCT05957692
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Brief Summary

The goal of this observational study is to verify the role of adipose tissue in determining the vitamin D serum level after monthly oral administration in subjects with vitamin D deficiency.

The main questions it aims to answer are:

* Adipose tissue represents a storage environment for vitamin D or it's an environment where vitamin D is sequestered and no longer released

* On the other hands, it's possible to verify whether the adipose tissue carries out a bi-modal activity towards vitamin D

* If adipose tissue exerts a bi-modal effect, it is possible to identify a specific threshold between the two effects Participants will undergo anthropometric measurements (height, weight, waist/hip ratio waist circumference) at baseline and after 6 months of intake of cholecalciferol 50,000 IU/month

Detailed Description

Vitamin D deficiency and insufficiency are prevalent worldwide, and various factors contribute to their occurrence, including low sun exposure, poor dietary intake, obesity, and abdominal obesity. Abdominal obesity, assessed by waist circumference (WC), is associated with metabolic syndrome and has been linked to low vitamin D levels. This study aimed to investigate the relationship between visceral adipose tissue (VAT) and vitamin D levels, particularly examining the potential threshold for vitamin D storage and sequestration by adipose tissue.

The study is conducted on patients with hypovitaminosis D in an internal medicine outpatient department. Blood samples for the evaluation of calcium and vitamin D levels are collected at baseline and after six months of monthly cholecalciferol supplementation. Ultrasonography are used to evaluate adipose tissue measurements, including subcutaneous adipose tissue thickness, VAT, preperitoneal adipose tissue (PPAT), and prerenal adipose tissue (PRAT). Anthropometric measures such as waist-to-hip ratio and waist-to-height ratio are also assessed.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-31
• Status Verified: 2023-07
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-14
• Last Update Submitted: 2023-07-14
• Study First Posted: 2023-07-24
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Vitamin D level < 20 ng/ml
• BMI > 24

Exclusion Criteria

• Administration of vitamin D metabolites in the last year
• Previous diagnosis of metabolic bone diseases
• Previous diagnosis of endocrine diseases
• Previous diagnosis of cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline of height measurements at 6 months	6 months	height expressed in cm
Change from Baseline of weight at 6 months	6 months	weight expressed in Kg
Change from Baseline of vitamin D levels at 6 months	6 months	blood sample expressed in ng/ml
Change from Baseline of waist and hip circumference at 6 months	6 months	waist and hip circumference expressed in centimeters
Change from Baseline of body adipose tissue at 6 months	6 months	body adipose index expressed in percentage
Change from Baseline of ultrasound adipose tissue measurement at 6 months	6 months	visceral, subcutaneous, pre-renal, pre-peritoneal adipose tissue expressed in millimeters

Secondary Outcome Measures

Name	Time	Method
Change from Baseline of calcium levels at 6 months	6 months	blood sample expressed in mg/dl

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Integrata; 🇮🇹 Verona, Italy