Clinical trial • Phase III • Immunology

colecalciferol for Healthy volunteers

Phase III trial of colecalciferol for Healthy volunteers. open-label, none/not specified-controlled. 150 participants.

Overview

open-label, none/not specified-controlled Phase III trial across 1 site in Czechia.

Recruits 150 No vulnerable population selected; no specific consent or assent handling is described in the CTIS record..

Pregnancy Exclusion: 6. Women who are pregnant, breastfeeding and planning a pregnancy at the time of the study
Vulnerable Population: No vulnerable population selected; no specific consent or assent handling is described in the CTIS record.

{"criterion_text":"- 1. I ndividuals who agreed to participate without any excluding conditions"}
{"criterion_text":"- 2. Age 20 27 or 65 85 years"}
{"criterion_text":"- 3. Women of childbearing potential ( must use highly effective contraception for the duration of the study"}
{"criterion_text":"- 4. BMI 18,5 and <30"}
{"criterion_text":"- 5. White race"}

{"criterion_text":"- 1. Recent vitamin D supplementation (in the past two months and during the study)"}
{"criterion_text":"- 2. Hypercalcemia"}
{"criterion_text":"- 3. Renal osteodystrophy with hypercalcemia"}
{"criterion_text":"- 4. Current therapy with thiazide diuretic s"}
{"criterion_text":"- 5. Current therapy with corticosteroids"}
{"criterion_text":"- 6. Women who are pregnant, breastfeeding and planning a pregnancy at the time of the study"}
{"criterion_text":"- 7. Endocrine disease or any medical condition with presumed autoimmune background (rheumatoid diseases, etc)"}
{"criterion_text":"- 8. Vitamin D levels 200 nmol/L"}
{"criterion_text":"- 9 Malabsorption syndromes"}
{"criterion_text":"- 10 Any type or staging of malignancy"}
{"criterion_text":"- 11 Any condition limiting the life expectancy to less than 12 months"}
{"criterion_text":"- 12 Calcium levels over 2,75 mmol/l"}
{"criterion_text":"- 1 3 Phosphate levels over 1,5 mmol/l"}
{"criterion_text":"- 14. A llergy to cholekalciferol or any other component of Vigantol"}

{"endpoint_text":"- Primary e nd point is Serum 25 hydroxycholecalciferol.","definition_or_measurement_approach":""}

{"endpoint_text":"- Secondary e nd p oints are Serum 24,25 dihydroxycholecalciferol levels and Serum 3 epi 25 hydroxycholecalciferol levels.","definition_or_measurement_approach":""}

Planned Sample Size: 150
Recruitment Window Months: 19
Consent Approach: Informed consent forms are listed in the CTIS documents (L1_Informed consent form V2-0_redacted and related documents). No further detail on age-specific consent/assent procedures or languages is provided in the record.

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 in CZ)
Maximum Dose: 8000 IU per day

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