CTIS2024-514528-17-00进行中（未招募）1 期
MULTICENTER, RANDOMIZED, BLIND AND CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF CHOLECALCIFEROL IN THE CORRECTION OF 25(OH)D DEFICIT IN SUBJECTS WITH SEVERE VITAMIN D DEFICIENCY, COMPARED TO CALCIFEDIOL. DTREAT STUDY. - RES-6128-C1
Itf Research Pharma S.L.0 个研究点目标入组 120 人开始时间: 2024年5月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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