Clinical trial NCT05957692: Vitamin D and Adipose Tissue: a Complex Relationship
Official title: Vitamin D and Adipose Tissue: Storage or Sequestration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovitaminosis D
Keywords: vitamin D
ultrasound
adipose tissue
storage
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 58
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the internal medicine clinic for cardiovascular evaluation.

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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline of vitamin D levels at 6 months
timeFrame: 6 months
measure: Change from Baseline of height measurements at 6 months
timeFrame: 6 months
measure: Change from Baseline of weight at 6 months
timeFrame: 6 months
measure: Change from Baseline of waist and hip circumference at 6 months
timeFrame: 6 months
measure: Change from Baseline of body adipose tissue at 6 months
timeFrame: 6 months
measure: Change from Baseline of ultrasound adipose tissue measurement at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from Baseline of calcium levels at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata
Study officials:
affiliation: Universita di Verona
name: Maria Teresa Valenti, BSc
role: STUDY_CHAIR
References:
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.
citation: 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.
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/medsci10030049.
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.