Hypovitaminosis DADIPOVITADNCT05957692
Vitamin D and Adipose Tissue: a Complex Relationship
An observational study of Hypovitaminosis D, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hypovitaminosis D
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients referred to the internal medicine clinic for cardiovascular evaluation.
Who may be able to join
- Vitamin D level < 20 ng/ml
- BMI > 24
Who cannot join
- Administration of vitamin D metabolites in the last year
- Previous diagnosis of metabolic bone diseases
- Previous diagnosis of endocrine diseases
- Previous diagnosis of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D and Adipose Tissue: Storage or Sequestration
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
Read the 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.
- Conditions
- Hypovitaminosis D
- Keywords
- vitamin D, ultrasound, adipose tissue, storage
- Medical subject headings
- Vitamin D Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of vitamin D levels at 6 months
blood sample expressed in ng/ml
Measured: 6 months
Change from Baseline of height measurements at 6 months
height expressed in cm
Measured: 6 months
Change from Baseline of weight at 6 months
weight expressed in Kg
Measured: 6 months
Change from Baseline of waist and hip circumference at 6 months
waist and hip circumference expressed in centimeters
Measured: 6 months
Change from Baseline of body adipose tissue at 6 months
body adipose index expressed in percentage
Measured: 6 months
Change from Baseline of ultrasound adipose tissue measurement at 6 months
visceral, subcutaneous, pre-renal, pre-peritoneal adipose tissue expressed in millimeters
Measured: 6 months
Secondary outcomes (1)
Change from Baseline of calcium levels at 6 months
blood sample expressed in mg/dl
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Jan 2020
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypovitaminosis DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Giuseppe Dalle Carbonare, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Maria Teresa Valenti, BSc, Study chair, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957692
- Sponsor's protocol ID
- ADIPOVITAD
- Acronym
- ADIPOVITAD
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30563215Dalle 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.
PubMed 28672793Pecoraro 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.
PubMed 36135834Valenti 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.
PubMed 32121611
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Adipose Tissue: Storage or Sequestration
- ClinicalTrials.gov ID
- NCT05957692
- Acronym / sponsor ID
- ADIPOVITAD / ADIPOVITAD
- Conditions
- Hypovitaminosis D
- Keywords
- vitamin D, ultrasound, adipose tissue, storage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the internal medicine clinic for cardiovascular evaluation.
Key inclusion criteria (2 listed)
- Vitamin D level < 20 ng/ml
- BMI > 24
Key exclusion criteria (4 listed)
- Administration of vitamin D metabolites in the last year
- Previous diagnosis of metabolic bone diseases
- Previous diagnosis of endocrine diseases
- Previous diagnosis of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Change from Baseline of calcium levels at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Results publication: PubMed 30563215Dalle 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.
- Results publication: PubMed 28672793Dalle 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.
- Results publication: PubMed 36135834Pecoraro 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.
- Results publication: PubMed 32121611Valenti 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Teresa Valenti, BSc study chair
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypovitaminosis D, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline of vitamin D levels at 6 months (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05957692, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.