Clinical trial • Phase III • Immunology
Colecalciferol for Healthy volunteers
Phase III trial of Colecalciferol for Healthy volunteers. open-label. 150 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 05-12-2024
- First CTIS Authorization Date
- 05-03-2025
Trial design
open-label Phase III trial across 1 site in Czechia.
- Open Label
- Yes
- Target Sample Size
- 150
Eligibility
Recruits 150 No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent and data protection consent documents are listed in the trial documents (L1_Informed consent form V4-0_non redacted; L1_Data protection consent form V3-0_non redacted; L2_Patient diary_CZ V3-0_non redacted; L2_Patient card_CZ V1-0). No assent procedures are indicated (adult population only)..
- Pregnancy Exclusion
- 6. Women who are pregnant, breastfeeding and planning a pregnancy at the time of the study
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent and data protection consent documents are listed in the trial documents (L1_Informed consent form V4-0_non redacted; L1_Data protection consent form V3-0_non redacted; L2_Patient diary_CZ V3-0_non redacted; L2_Patient card_CZ V1-0). No assent procedures are indicated (adult population only).
Inclusion criteria
- {"criterion_text":"- 1. Healthy individuals of any gender who agreed to participate without any excluding conditions\n- 2. Age 20 27 or 65 85 years\n- 3. Women of childbearing potential ( must use highly effective contraception for the duration of the study\n- 4. BMI 18,5 and <30\n- 5. White race\n- 6. Healthy individuals or individuals with stable chronic disease not listed in exclusion criteria"}
Exclusion criteria
- {"criterion_text":"- 1. Recent vitamin D supplementation (in the past two months and during the study)\n- 2. Hypercalcemia\n- 3 Renal osteodystrophy with hypercalcemia\n- 4. Current therapy with thiazide diuretics\n- 5. Current therapy with corticosteroids\n- 6. Women who are pregnant, breastfeeding and planning a pregnancy at the time of the study\n- 7. Endocrine disease or any medical co ndition with presumed autoimmune background (rheumatoid diseases, etc)\n- 8. Vitamin D levels 1 00 nmol/L\n- 9 Malabsorption syndromes\n- 10 Any type or staging of malignancy\n- 11 Any condition limiting the life expectancy to less than 12 months\n- 12 C alcium levels over 2,75 mmol/l\n- 1 3 Phosphate levels over 1,5 mmol/l\n- 14. A llergy to cholecalciferol or any other component of Vigantol"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Primary end point is Serum 25 hydroxycholecalciferol.","definition_or_measurement_approach":"Measurement of serum 25-hydroxycholecalciferol concentration."}
Secondary endpoints
- {"endpoint_text":"- Secondary end points are Serum 24,25-dihydroxycholecalciferol levels and Serum 3-epi-25-hydroxycholecalciferol levels.","definition_or_measurement_approach":"Measurement of serum 24,25-dihydroxycholecalciferol and serum 3-epi-25-hydroxycholecalciferol concentrations."}
Recruitment
- Planned Sample Size
- 150
- Recruitment Window Months
- 19
- Consent Approach
- Informed consent obtained from adult participants. Subject information and informed consent documents are provided (documents listed: L1_Informed consent form V4-0_non redacted; L1_Data protection consent form V3-0_non redacted; L2_Patient diary_CZ V3-0_non redacted; L2_Patient card_CZ V1-0). No assent process is indicated (trial enrols adults). Documents appear to be in Czech (filenames include _CZ).
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 150
Czechia
- Earliest CTIS Part Ii Submission Date
- 05-12-2024
- Latest Decision Or Authorization Date
- 05-03-2025
- Processing Time Days
- 90
- Number Of Sites
- 1
- Number Of Participants
- 150
Sites
- Site Name
- Fakultni Nemocnice Plzen
- Department Name
- II. Internal Clinic
- Contact Person Name
- Otto Mayer
- Contact Person Email
- mayero@fnplzen.cz
Sponsor
Primary sponsor
- Full Name
- Fakultni Nemocnice Plzen
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Czechia
Investigational products
- Investigational Product Name
- Vigantol 0,5 mg/ml perorální kapky, roztok
- Active Substance
- Colecalciferol
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation number 86/1140/93-C, CZ)
- Maximum Dose
- 4000 IU
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