Vitamin D and Adipose Tissue: a Complex Relationship

Hypovitaminosis D Clinical Trial

— ADIPOVITAD  

Official title:

Vitamin D and Adipose Tissue: Storage or Sequestration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05957692
• Other study ID #: ADIPOVITAD
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2023
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Avitaminosis
• Hypovitaminosis D
• Rickets
• Vitamin D Deficiency

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Integrata	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Dalle Carbonare L, Valenti MT, Del Forno F, Caneva E, Pietrobelli A. Vitamin D: Daily vs. Monthly Use in Children and Elderly-What Is Going On? Nutrients. 2017 Jun 24;9(7):652. doi: 10.3390/nu9070652. — View Citation

Dalle Carbonare L, Valenti MT, Del Forno F, Piacentini G, Pietrobelli A. Vitamin D Daily versus Monthly Administration: Bone Turnover and Adipose Tissue Influences. Nutrients. 2018 Dec 6;10(12):1934. doi: 10.3390/nu10121934. — View Citation

Pecoraro L, Nisi F, Serafin A, Antoniazzi F, Dalle Carbonare L, Piacentini G, Pietrobelli A. Vitamin D Supplementation in the Assessment of Cardiovascular Risk Factors in Overweight and Obese Children. Med Sci (Basel). 2022 Sep 5;10(3):49. doi: 10.3390/me — View Citation

Valenti MT, Pietrobelli A, Romanelli MG, Franzolin E, Malerba G, Zipeto D, Mottes M, Dalle Carbonare L. Molecular and Lifestyle Factors Modulating Obesity Disease. Biomedicines. 2020 Mar 1;8(3):46. doi: 10.3390/biomedicines8030046. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline of vitamin D levels at 6 months	blood sample expressed in ng/ml	6 months
Primary	Change from Baseline of height measurements at 6 months	height expressed in cm	6 months
Primary	Change from Baseline of weight at 6 months	weight expressed in Kg	6 months
Primary	Change from Baseline of waist and hip circumference at 6 months	waist and hip circumference expressed in centimeters	6 months
Primary	Change from Baseline of body adipose tissue at 6 months	body adipose index expressed in percentage	6 months
Primary	Change from Baseline of ultrasound adipose tissue measurement at 6 months	visceral, subcutaneous, pre-renal, pre-peritoneal adipose tissue expressed in millimeters	6 months
Secondary	Change from Baseline of calcium levels at 6 months	blood sample expressed in mg/dl	6 months