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Musculoskeletal DiseasesPhase 4DON3NCT06508242

Effects Of Vitamin D On Bone, Muscle, And Adipose Tissue In Obese Subjects

A Phase 4 study testing Cholecalciferol in people with Musculoskeletal Diseases and Inflammation, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Obesity has emerged as a risk factor in the onset of bone, muscle and adipose tissue impairments that are further aggravated by vitamin D deficiency. A link of an active bone-muscle-adipose axis is represented by Wnt pathway. Read more about this study

Who is it for?
Ages 55 to 75 years
What is being tested?
Cholecalciferol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteItaly
Study dates
28 Apr 2023to 31 Dec 2025
Phase
Phase 4
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 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ambulatory willing and able to provide informed consent;
  • post-menopausal women (55-75 y.o.) and age-matched men;
  • BMI 30 >= kg/m2;
  • serum 25OHD < 20 ng/ml
  • hip replacement surgery due to osteoarthritis according to orthopedic clinical decision

Who cannot join

  • eGFR <40 ml/min/1.72 m2 by EPI formula (21);
  • hypercalcemia (>10.5 mg/dL);
  • osteoporosis (hip or vertebral t-score >-2.5);
  • conditions affecting bone
  • vitamin D and/or calcium metabolism (chronic liver disease, renal failure, malabsorption, hypercortisolism);
  • medications altering bone metabolism (e.g. denosumab, bisphosphonates, teriparatide, glucocorticoids, aromatase inhibitors, estrogen);
  • enrollment in an interventional clinical trial in the previous 3 months.

Trial locations and contacts

1 site in 1 country.

Nicola Napoli, PhD contact

+3906225419151

N.Napoli@policlinicocampus.it

Flavia Tramontana, PhD contact

+3906225419152

f.tramontana@unicampus.it

Italy1 site, 1 recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico di Roma

    Roma, RM, 00128

    Nicola Napoli, PhD, +390622541951, N.Napoli@policlinicocampus.it

    Flavia Tramontana, +390622541952, f.tramontana@unicampus.it

    Recruiting

Other trials in Italy

About this study

Official title: Effects Of Vitamin D On Bone, Muscle, And Adipose Tissue In Obese Subjects: A Randomized, Double-Blind, Placebo-Controlled Study

Obesity has emerged as a risk factor in the onset of bone, muscle and adipose tissue impairments that are further aggravated by vitamin D deficiency. A link of an active bone-muscle-adipose axis is represented by Wnt pathway. This study will test the hypothesis that vitamin D improves bone, muscle, and adipose tissue health through a positive modulation of Wnt pathway. It will be carried out a double-blind, placebo-controlled study of cholecalciferol supplementation in vitamin D-deficient obese adults. Specific aims will be: 1) to test the direct effect of vitamin D on Wnt signaling in bone, muscle, and adipose tissue; 2) to evaluate muscle mass and strength; 3) to assess changes in vitamin D status across different administration strategy (weekly, fortnightly, monthly).

This study will provide not only insight of new mechanisms involved in the pathophysiology of obesity-related musculoskeletal impairments but also evidence for new treatment recommendations for vitamin D deficiency in obesity.

Being tested
Cholecalciferol, Placebo
Medical subject headings
Musculoskeletal Diseases, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06508242
Study groupRoleWhat they receive
Vitamin D intervention groupActive comparator50.000 IU of oral cholecalciferol/week
Receives: Drug: Cholecalciferol
Placebo groupPlacebo comparatorPlacebo treatment/week
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WNT pathway regulation

    Specifically, WNT10b, WNT5a, sFRP5, pGSK-3ß-Ser9 and total GSK-3ß expression will be evaluated and subsequently confirmed by RT-PCR and Western-blot analysis on adipose and muscle tissue. Serum sclerostin,DDK-1 and sFRP5 will be also evaluated by ELISA

    Measured: from 6 to 30 months

Secondary outcomes (13)

  1. Muscle strength and function

    • Gene involved in myogenesis will be analyzed by RT-PCR (Relative Expression) and Western-blot (Relative Abundance).

    Measured: from 0 to 32 months

  2. Muscle strength and function

    • RNAseq will be performed on muscle biopsies to address changes in the transcript profile and subsequent gene enrichment analysis related to vitamin D supplementation

    Measured: from 0 to 32 months

  3. Muscle strength and function

    • Exosomal-miRNAs will be isolated from treated and untreated adipose tissue with Vitamin D

    Measured: from 0 to 32 months

  4. Muscle strength and function

    Following tests will be performed:

    • MRI and total body DXA to characterize muscle health status and muscle quality

    Measured: from 0 to 32 months

  5. Muscle strength and function

    • Muscle quality will be assessed also by calculating the ratio of Lower extremity (LE) strength to LE lean body mass (by DXA, g/cm^2)

    Measured: from 0 to 32 months

  6. Muscle strength and function

    • Handled dynamometer (to test muscle strength, Kg).

    Measured: from 0 to 32 months

  7. Muscle strength and function

    • Physical performance evaluation by modified and gait-speed test (m/s).

    Measured: from 0 to 32 months

  8. Muscle strength and function

    • Validated questionnaires for sarcopenia assessment such as SARC-F and MSRA (Units on a scale)

    Measured: from 0 to 32 months

  9. Effects of inflammation and WNT pathway on adipose tissue

    • Analysis of gene and protein expression of molecules related to Inflammation and the effects of WNT pathway on adipose tissue

    Measured: from 0 to 32 months

  10. Effects of inflammation and WNT pathway on adipose tissue

    • RNA transcription will be performed as described above, as well as exosome analysis.

    Measured: from 0 to 32 months

  11. Effects of inflammation and WNT pathway on bone tissue

    • Analysis of gene expression of the genes related to WNT pathway

    Measured: from 0 to 32 months

  12. Effects of inflammation and WNT pathway on bone tissue

    • An immunohistochemistry assay will be performed on the bone to analyze the number and localisation of Teff and Treg cells.

    Measured: from 0 to 32 months

  13. Effects of inflammation and WNT pathway on bone tissue

    • Synovial fluid: measurement of pro- and anti-inflammatory/metabolic molecules using the Luminex technology

    Measured: from 0 to 32 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2024
  2. Study start28 Apr 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06508242
Sponsor's protocol ID
73.20
Acronym
DON3
Status last verified
Mar 2024
First submitted
25 Mar 2024
Last updated
18 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cholecalciferol in people with Musculoskeletal Diseases and Inflammation, run by Fondazione Policlinico Universitario Campus Bio-Medico 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nicola Napoli, PhD (+3906225419151, N.Napoli@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WNT pathway regulation (time frame: from 6 to 30 months). 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 NCT06508242.

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 18 Jul 2024.

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