A Phase Iii Open Label Study Controlled by Vitamin D3 Supplementation and the Differences Between Young Adults and Senior Population

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fakultni Nemocnice Plzen

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2024-10-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Fakultni Nemocnice Plzen

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 1

1. The secondary aim of the study is to evaluate the effect of viral respiratory diseases on vitamin D 3 levels and to assess the need for additional supplementation based on the results

Conditions and MedDRA coding

Healthy population

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. I ndividuals 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

Exclusion criteria 1

1. 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 diuretic s 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 condition with presumed autoimmune background (rheumatoid diseases, etc) 8. Vitamin D levels 200 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 Calcium 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary e nd point is Serum 25 hydroxycholecalciferol.

Secondary endpoints 1

1. Secondary e nd p oints are Serum 24,25 dihydroxycholecalciferol levels and Serum 3 epi 25 hydroxycholecalciferol levels.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fakultni Nemocnice Plzen

Sponsor organisation

Fakultni Nemocnice Plzen

Address

Edvarda Benese 1128/13, Jizni Predmesti Jizni Predmesti

City

Plzen 3

Postcode

301 00

Country

Czechia

Scientific contact point

Organisation

Fakultni Nemocnice Plzen

Contact name

MUDr. Hatakova Hedvika

Public contact point

Organisation

Fakultni Nemocnice Plzen

Contact name

MUDr. Hatakova Hedvika

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications