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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05957692
Other study ID # ADIPOVITAD
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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