Vitamin D and Adipose Tissue: a Complex Relationship (ADIPOVITAD)

Vitamin D and Adipose Tissue: Storage or Sequestration

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

Study Overview

• Status: Completed
• Conditions: Hypovitaminosis D

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 Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • Azienda Ospedaliera Universitaria Integrata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the internal medicine clinic for cardiovascular evaluation.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline of vitamin D levels at 6 months	blood sample expressed in ng/ml	6 months
Change from Baseline of height measurements at 6 months	height expressed in cm	6 months
Change from Baseline of weight at 6 months	weight expressed in Kg	6 months
Change from Baseline of waist and hip circumference at 6 months	waist and hip circumference expressed in centimeters	6 months
Change from Baseline of body adipose tissue at 6 months	body adipose index expressed in percentage	6 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline of calcium levels at 6 months	blood sample expressed in mg/dl	6 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
• Investigators: Study Chair: Maria Teresa Valenti, BSc, Universita di Verona

Publications and helpful links

General Publications

• 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.
• 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.
• 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/medsci10030049.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Estimated): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: ultrasound; vitamin D; adipose tissue; storage
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Musculoskeletal Diseases; Deficiency Diseases; Malnutrition; Bone Diseases; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Vitamin D Deficiency; Rickets; Avitaminosis
• Other Study ID Numbers: ADIPOVITAD

Drug and device information, study documents

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