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

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ClinicalTrials.gov Identifier: NCT05957692

Recruitment Status : Completed

First Posted : July 24, 2023

Last Update Posted : July 24, 2023

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Sponsor:

Information provided by (Responsible Party):

Luca Giuseppe Dalle Carbonare, Azienda Ospedaliera Universitaria Integrata Verona

Study Description

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

Condition or disease
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 Design

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Study Type :	Observational
Actual Enrollment :	58 participants
Observational Model:	Case-Only
Time Perspective:	Retrospective
Official Title:	Vitamin D and Adipose Tissue: Storage or Sequestration
Actual Study Start Date :	January 1, 2020
Actual Primary Completion Date :	November 30, 2022
Actual Study Completion Date :	December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Genetic and Rare Diseases Information Center resources: Rickets

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Change from Baseline of calcium levels at 6 months [ Time Frame: 6 months ]
blood sample expressed in mg/dl

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	60 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Sampling Method:	Non-Probability Sample

Study Population

Patients referred to the internal medicine clinic for cardiovascular evaluation.

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05957692

Locations

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Italy
Azienda Ospedaliera Universitaria Integrata
Verona, Italy, 37134

Sponsors and Collaborators

Azienda Ospedaliera Universitaria Integrata Verona

Investigators

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Study Chair:	Maria Teresa Valenti, BSc	Universita di Verona

More Information

Publications of Results:

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.

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Responsible Party:	Luca Giuseppe Dalle Carbonare, Associate Professor, Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier:	NCT05957692
Other Study ID Numbers:	ADIPOVITAD
First Posted:	July 24, 2023 Key Record Dates
Last Update Posted:	July 24, 2023
Last Verified:	July 2023

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Luca Giuseppe Dalle Carbonare, Azienda Ospedaliera Universitaria Integrata Verona:


vitamin D ultrasound adipose tissue storage

Additional relevant MeSH terms:

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Rickets Avitaminosis Vitamin D Deficiency Deficiency Diseases Malnutrition Nutrition Disorders	Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Calcium Metabolism Disorders

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