REQUIRED DOSE OF CHOLECALCIFEROL IN THE MANAGEMENT OF VITAMIN D DEFICIENCY AND INSUFFICIENCY IN POSTMENOPAUSAL WOME

Phase 1

Recruiting

Conditions: POSTMENOPAUSAL WOMEN
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: CTIS2023-504664-42-02

Lead Sponsor: Clinica Palacios Madrid S.L.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy of the use of Cholecalciferol in postmenopausal women with vitamin D deficiency or insufficiency;Secondary Objective: Efficacy in maintenance doses of Cholecalciferol, To evaluate patient satisfaction with the supplement.;Primary end point(s): To evaluate the efficacy of cholecalciferol, serum vitamin D titration will be performed at the initial view, view 3 and final visit.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):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.