Overview
Sponsor-declared trial summary
POSTMENOPAUSAL WOMEN
Efficacy of the use of Cholecalciferol in postmenopausal women with vitamin D deficiency or insufficiency
Key facts
- Sponsor
- Clinica Palacios Madrid S.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 3 Jul 2023 → ongoing
- Decision date (initial)
- 2023-06-27
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Efficacy of the use of Cholecalciferol in postmenopausal women with vitamin D deficiency or insufficiency
Secondary objectives 2
- Efficacy in maintenance doses of Cholecalciferol
- To evaluate patient satisfaction with the supplement.
Conditions and MedDRA coding
POSTMENOPAUSAL WOMEN
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-504664-42-00 | REQUIRED DOSE OF CHOLECALCIFEROL IN THE MANAGEMENT OF VITAMIN D DEFICIENCY AND INSUFFICIENCY IN POSTMENOPAUSAL WOMEN | Clinica Palacios Madrid S.L. |
| 2023-504664-42-01 | REQUIRED DOSE OF CHOLECALCIFEROL IN THE MANAGEMENT OF VITAMIN D DEFICIENCY AND INSUFFICIENCY IN POSTMENOPAUSAL WOMEN | Clinica Palacios Madrid S.L. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Female patients aged ≥ 45 years.
- Menopausal women with more than one year of amenorrhea.
- Women with deficiency(40pt) of Vit D (25(OH) Vit D < 20 ng/ml), and with insufficiency(40pt) of Vit D (25(OH) Vit D, 20-30 ng/ml).
- Women who are willing to participate, and who are able to understand the explanation given to them about the nature of the study.
- Signed written informed consent.
Exclusion criteria 5
- Patients with chronic decompensated diseases
- Mental condition that prevents them from consenting to participate in the study.
- Optimal vitamin D levels
- Allergy to one of the product's compounds.
- Concomitant use, or in the last 4 weeks, of other products containing vitamin D.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To evaluate the efficacy of cholecalciferol, serum vitamin D titration will be performed at the initial view, view 3 and final visit.
Secondary endpoints 1
- Vitamin D levels will be evaluated in the four groups to see if with 1000 IU normal levels are maintained. The patients' satisfaction with the treatment will be evaluated.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Lundeos 20.000 UI cápsulas blandas
PRD8428123 · Product
- Active substance
- Colecalciferol
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 2857 IU international unit(s)
- Max total dose
- 80000 IU international unit(s)
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- A11CC05 — COLECALCIFEROL
- Marketing authorisation
- 85.512
- MA holder
- THERAMEX IRELAND LIMITED
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Clinica Palacios Madrid S.L.
- Sponsor organisation
- Clinica Palacios Madrid S.L.
- Address
- Calle Antonio Acuna 9
- City
- Madrid
- Postcode
- 28009
- Country
- Spain
Scientific contact point
- Organisation
- Clinica Palacios Madrid S.L.
- Contact name
- Santiago Palacios
Public contact point
- Organisation
- Clinica Palacios Madrid S.L.
- Contact name
- Clinica Palacios
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 80 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2023-07-03 | 2023-07-18 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-03 | Spain | Acceptable 2023-06-27
|
2023-06-27 |