NCT05957692

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

2.9 years

First QC Date

July 7, 2023

Last Update Submit

July 14, 2023

Conditions

Hypovitaminosis D

Keywords

vitamin Dultrasoundadipose tissuestorage

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • Change from Baseline of calcium levels at 6 months

    6 months

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to the internal medicine clinic for cardiovascular evaluation.

You may qualify if:

  • Vitamin D level \< 20 ng/ml
  • BMI \> 24

You may not qualify if:

  • Administration of vitamin D metabolites in the last year
  • Previous diagnosis of metabolic bone diseases
  • Previous diagnosis of endocrine diseases
  • Previous diagnosis of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata

Verona, 37134, Italy

Location

Related Publications (4)

  • 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.

    PMID: 30563215RESULT

  • 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.

    PMID: 28672793RESULT

  • 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.

    PMID: 36135834RESULT

  • 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.

    PMID: 32121611RESULT

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Maria Teresa Valenti, BSc

    Universita di Verona

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 24, 2023

Study Start

January 1, 2020

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations

IT(1)