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The effects of vitamin D on bone, muscle and adipose tissue: a randomized double-blind phase IV study
EU CTIS ID: 2025-520869-52-00
What this study is testing
To evaluate the effect of cholecalciferol supplementation on inflammation in obese patients with vitamin D deficiency
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Obtaining written informed consent
- Willingness to adhere to the procedures foreseen by the study, as reported in the informed consent
- Post-menopausal women between the ages of 55 and 75 and men of the same age for whom hip or knee replacement surgery has been scheduled
- BMI >= 30 kg/m2
- 25(OH)D levels < 20 ng/ml
You likely can't join if
- eGFR < 40 ml/min./1.72 m2 estimated via EPI formula
- Osteoporosis (femoral or vertebral t-score > -2.5)
- Pathologies at the site of surgery
- Participation in interventional clinical trials in the previous 3 months
- Hypersensitivity to cholecalciferol or to any of the excipients
- Hypercalcemia (>10.5 mg/dL)
See the full eligibility criteria
- Obtaining written informed consent
- Willingness to adhere to the procedures foreseen by the study, as reported in the informed consent
- Post-menopausal women between the ages of 55 and 75 and men of the same age for whom hip or knee replacement surgery has been scheduled
- BMI >= 30 kg/m2
- 25(OH)D levels < 20 ng/ml
- eGFR < 40 ml/min./1.72 m2 estimated via EPI formula
- Osteoporosis (femoral or vertebral t-score > -2.5)
- Pathologies at the site of surgery
- Participation in interventional clinical trials in the previous 3 months
- Hypersensitivity to cholecalciferol or to any of the excipients
- Hypercalcemia (>10.5 mg/dL)
- Nephrolithiasis known by medical history
- 4. Conditions that can alter the metabolism of calcium and vitamin D (primary hyperparathyroidism, hyperthyroidism, chronic renal failure, liver failure, hypercortisolism, malabsorption, HIV)
- 5. Use of drugs that can alter bone metabolism (estrogens, raloxifene, tamoxifen, bisphosphonates, denosumab, teriparatide, GnRH analogues, use of at least 5 mg per day of glucocorticoids for ≥ 3 months, anabolic steroids, dilantin, antiretrovirals, radiation therapy)
- Immobilized patients
- Alcohol and/or tobacco abuse
- Clinical history of bone metastases or neoplastic bone diseases
- Paget's disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.