Otevřená studie fáze III kontrolovaná suplementací vitaminu D3 a rozdíly mezi mladými dospělými a seniory

Phase 3

Not yet recruiting

• Conditions: Healthy population

• Registration Number: 2024-519747-15-00
• Lead Sponsor: Fakultni Nemocnice Plzen

Brief Summary

The main objective of this study is to compare the efficacy of vitamin D3 supplementation

in the young and elderly population with the same dosing schedule and to develop an

effective supplementation model for each age group based on the differences found.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Healthy individuals of any gender who agreed to participate without any excluding conditions 2. Age 20 27 or 65 85 years 3. Women of childbearing potential ( must use highly effective contraception for the duration of the study 4. BMI 18,5 and <30 5. White race 6. Healthy individuals or individuals with stable chronic disease not listed in exclusion criteria

Exclusion Criteria

1. Recent vitamin D supplementation (in the past two months and during the study) 2. Hypercalcemia 3 Renal osteodystrophy with hypercalcemia 4. Current therapy with thiazide diuretics 5. Current therapy with corticosteroids 6. Women who are pregnant, breastfeeding and planning a pregnancy at the time of the study 7. Endocrine disease or any medical co ndition with presumed autoimmune background (rheumatoid diseases, etc) 8. Vitamin D levels 1 00 nmol/L 9 Malabsorption syndromes 10 Any type or staging of malignancy 11 Any condition limiting the life expectancy to less than 12 months 12 C alcium levels over 2,75 mmol/l 1 3 Phosphate levels over 1,5 mmol/l 14. A llergy to cholecalciferol or any other component of Vigantol

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point is Serum 25 hydroxycholecalciferol.		Primary end point is Serum 25 hydroxycholecalciferol.

Secondary Outcome Measures

Name	Time	Method
Secondary end points are Serum 24,25-dihydroxycholecalciferol levels and Serum 3-epi-25-hydroxycholecalciferol levels.		Secondary end points are Serum 24,25-dihydroxycholecalciferol levels and Serum 3-epi-25-hydroxycholecalciferol levels.

Trial Locations

Locations (1)

Fakultni Nemocnice Plzen; 🇨🇿 Plzen 3, Czechia

Fakultni Nemocnice Plzen

🇨🇿Plzen 3, Czechia

Otto Mayer

Site contact

+420377402496

mayero@fnplzen.cz