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Completed

NCT Number: NCT05957692

Vitamin D and Adipose Tissue: a Complex Relationship

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

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Key information

Conditions

Hypovitaminosis D Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Universitaria Integrata

Verona, 37134, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change from Baseline of vitamin D levels at 6 months

    Time frame: 6 months

    blood sample expressed in ng/ml

  2. Change from Baseline of height measurements at 6 months

    Time frame: 6 months

    height expressed in cm

  3. Change from Baseline of weight at 6 months

    Time frame: 6 months

    weight expressed in Kg

  4. Change from Baseline of waist and hip circumference at 6 months

    Time frame: 6 months

    waist and hip circumference expressed in centimeters

  5. Change from Baseline of body adipose tissue at 6 months

    Time frame: 6 months

    body adipose index expressed in percentage

  6. 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 outcomes

  1. Change from Baseline of calcium levels at 6 months

    Time frame: 6 months

    blood sample expressed in mg/dl

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

Vitamin D and Adipose Tissue: Storage or Sequestration

Acronym: ADIPOVITAD

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 24, 2023
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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