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.
- Conditions
- Severe vitamin D deficiencyTherapeutic area: Not possible to specify
- Registration Number
- CTIS2024-514528-17-00
- Lead Sponsor
- Itf Research Pharma S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
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, romosozumab) 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, 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), or are not suitable candidates to receive the investigational product., 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 5 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/inducers of the cytochrome P450 pathway such as phenytoin and phenobarbital, long-term corticosteroids (> 3 months of treatment), rifampicin, highly active antiretroviral agents, some antibiotics such as penicillin, neomycin and chloramphenicol, actinomycin, imidazole antifungals, cardiac glycosides, verapamil, thiazides and antituberculous drugs (isoniazid))., 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method