Colecalciferol for Severe vitamin D deficiency

Inclusion criteria

• {"criterion_text":"- Adults of both sexes aged ≥ 18 years.\n- Patients with severe vitamin D deficiency defined as 25(OH)D ≤ 12 ng/ml.\n- Patients with a body mass index between 18.5-34.9 kg/m2 (both included).\n- Patients who have given their written informed consent to participate in the study."}

Exclusion criteria

• {"criterion_text":"- Patients who have malabsorption syndrome or have undergone bariatric surgery.\n- 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.\n- Women who are pregnant or intend to become pregnant during the study intervention period and/or breastfeeding women\n- Patients with hypersensitivity to any of the active ingredients or excipients of any of the study treatments.\n- 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.\n- 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.\n- Patients with severe hepatic impairment.\n- Patients with nephrolithiasis, chronic kidney disease, severe renal impairment and/or creatinine clearance < 30 mL/min.\n- Patients with a clinical history of hypercalcemia and/or hypercalciuria, or who currently have any of these diseases.\n- Patients diagnosed with primary hyperparathyroidism, hyperthyroidism, and/or hypoparathyroidism.\n- Cancer patients currently or in the 2 years prior to signing the Informed Consent.\n- Patients with sarcoidosis, tuberculosis, or other granulomatous diseases.\n- 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.\n- 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."}

Primary endpoints

• {"endpoint_text":"- Percentage of patients achieving 25(OH)D levels ≥ 20 ng/ml after 6 weeks of treatment.","definition_or_measurement_approach":"Measured by serum 25(OH)D concentration at 6 weeks; reported as the percentage of patients with 25(OH)D ≥ 20 ng/ml after 6 weeks of treatment."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients achieving 25(OH)D levels ≥ 20 ng/ml after 12 (Phase I+II) weeks of treatment.\n- Percentage of patients achieving different levels of 25(OH)D after 6 (Phase I) and 12 (Phase I+II) weeks of treatment based on post-treatment 25(OH)D values.\n- Percentage of patients achieving different levels of 25(OH)D after 12 (Phase II) weeks of treatment, based on values of 25(OH)D after 6 weeks of treatment (Phase I).\n- Absolute and relative differences in 25(OH)D concentrations after 6 (Phase I) and 12 (Phase I+II) weeks of treatment compared to baseline values and after 12 (Phase II) weeks of treatment compared to the values of week 6.\n- Plasma 25(OH)D curves: the variable of 25(OH)D concentration will be represented at the three time points measured: baseline visit, visit 2 (after 6 weeks of treatment, Phase I) and visit 3 (after 12 weeks of treatment, Phase II and after the maintenance phase, Phase IIb).\n- Absolute and relative differences in vitamin D metabolism parameters after 6 (Phase I) and 12 (Phase I+II) weeks of treatment compared to baseline and after 12 weeks (Phase II only) of treatment compared to values after 6 weeks of treatment.\n- Absolute and relative differences and frequency of values outside the normal range of bone metabolism parameters after 6 (Phase I) and 12 weeks (Phase I+II) of treatment with respect to baseline values and after 12 weeks (Phase II only) of treatment with respect to values after 6 weeks of treatment.\n- The degree of adherence will be calculated after 6 (Phase I) and 12 (Phase II) weeks of treatment during the study period.\n- The degree of satisfaction with the treatment will be assessed by both the patient and the investigator independently at 6 (Phase I) and 12 (Phase II) weeks of treatment using a Likert-type question with 4 options: \"How satisfied are you with the study medication?\", possible answers: Very dissatisfied, dissatisfied, satisfied, and very satisfied.\n- The degree of treatment recommendation perceived by the investigator will be evaluated after 12 weeks of treatment through a question with a 4-choice Likert answer: \"What is the degree of recommendation of the study medication?\", possible answers: very positive, positive, negative and very negative. The causes of such a response should also be described, having to select one or more of the following options: efficacy, safety, pharmacokinetic profile, available clinical evidence, ease of of admin\n- Calcium intake will be assessed at baseline by the absolute value of calcium consumed per day by the patient. This value will be estimated by the SEIOMM daily calcium intake calculator.\n- The safety of treatment during the study will be assessed by the Incidence of Adverse Events and Serious Adverse Events over the entire study period.","definition_or_measurement_approach":"Measures are based primarily on serum 25(OH)D concentration at specified time points (baseline, 6 weeks, 12 weeks) and derived categories/changes (percentages achieving thresholds, absolute/relative changes, plasma concentration curves). Other measures include vitamin D metabolism parameters, bone metabolism parameters, adherence calculated at 6 and 12 weeks, patient and investigator satisfaction measured by 4-option Likert questions, investigator recommendation by 4-option Likert question with selectable reasons, baseline calcium intake estimated by the SEIOMM daily calcium intake calculator, and safety assessed by incidence of AEs and SAEs over the study period."}

Spain

Earliest CTIS Part Ii Submission Date

19-07-2024

Latest Decision Or Authorization Date

24-02-2026

Processing Time Days

585

Number Of Sites

12

Number Of Participants

120

Primary sponsor

Full Name

Itf Research Pharma S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Contract research organisations

Name

Adknoma Health Research S.L.

Responsibilities

Sponsor duties codes: 1,10,12,3,5,6,8 (as listed in record); contact regulatory@adknoma.com

Third parties

• {"country":"Spain","full_name":"Adknoma Health Research S.L.","duties_or_roles":"Codes: 1,10,12,3,5,6,8","organisation_type":"Pharmaceutical company"}