BridgeMD
MULTICENTER, RANDOMIZED, BLIND AND CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY IN THE CORRECTION OF DEFICIT IN SUBJECTS WITH SEVERE VITAMIN D DEFICIENCY. DTREAT STUDY.
EU CTIS ID: 2024-514528-17-00
What this study is testing
To assess the efficacy in correcting 25(OH)D deficiency after 6 weeks of treatment with xxxxxx in patients with severe vitamin D deficiency, compared with xxxxxx.
- 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
- Adults of both sexes aged ≥ 18 years.
- Patients with severe vitamin D deficiency defined as 25(OH)D ≤ 12 ng/ml.
- Patients with a body mass index between 18.5-34.9 kg/m2 (both included).
- Patients who have given their written informed consent to participate in the study.
You likely can't join if
- Patients who have malabsorption syndrome or have undergone bariatric surgery.
- Patients with other diseases, alterations or on treatment with drugs (e.g. treatment with teriparatide) that, in the opinion of the investigator, may modify the development of the study.
- Women who are pregnant or intend to become pregnant during the study intervention period and/or breastfeeding women
- Patients with hypersensitivity to any of the active ingredients or excipients of any of the study treatments.
- Patients who have received an investigational product within 30 days prior to inclusion in the study, or plan to do so during the course of the study.
- Patients who, in the opinion of the investigator, are not suitable candidates to receive the investigational product, or have difficulty in comprehension, reading or writing, or any difficulty in following the requirements of the study, such as lack of adherence to the study treatment, inability to collect relevant data (demographic and/or clinical characteristics), with the exception of patients with dementia who have a legal representative.
See the full eligibility criteria
- Adults of both sexes aged ≥ 18 years.
- Patients with severe vitamin D deficiency defined as 25(OH)D ≤ 12 ng/ml.
- Patients with a body mass index between 18.5-34.9 kg/m2 (both included).
- Patients who have given their written informed consent to participate in the study.
- Patients who have malabsorption syndrome or have undergone bariatric surgery.
- Patients with other diseases, alterations or on treatment with drugs (e.g. treatment with teriparatide) that, in the opinion of the investigator, may modify the development of the study.
- Women who are pregnant or intend to become pregnant during the study intervention period and/or breastfeeding women
- Patients with hypersensitivity to any of the active ingredients or excipients of any of the study treatments.
- Patients who have received an investigational product within 30 days prior to inclusion in the study, or plan to do so during the course of the study.
- Patients who, in the opinion of the investigator, are not suitable candidates to receive the investigational product, or have difficulty in comprehension, reading or writing, or any difficulty in following the requirements of the study, such as lack of adherence to the study treatment, inability to collect relevant data (demographic and/or clinical characteristics), with the exception of patients with dementia who have a legal representative.
- Patients with severe hepatic impairment.
- Patients with nephrolithiasis, chronic kidney disease, severe renal impairment and/or creatinine clearance < 30 mL/min.
- Patients with a clinical history of hypercalcemia and/or hypercalciuria, or who currently have any of these diseases.
- Patients diagnosed with primary hyperparathyroidism, hyperthyroidism, and/or hypoparathyroidism.
- Cancer patients currently or in the 2 years prior to signing the Informed Consent.
- Patients with sarcoidosis, tuberculosis, or other granulomatous diseases.
- Patients on medication that has a known interaction on vitamin D absorption or metabolism in the week prior to the screening visit or who plan to initiate it during the course of the study (e.g., Antiepileptic drugs that induce the cytochrome P450 pathway, such as phenytoin and phenobarbital. Corticosteroids given long-term (> 3 months of treatment) orally or systemically, or inhaled in high doses.
- Patients who have received a nutritional supplement or treatment containing ≥ 800 IU of vitamin D in the month prior to inclusion or plan to receive vitamin D and/or calcium supplementation/treatment during the study.
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, 18-64 years, 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.