The effect of calcium and vitamin D on the heartmusclef unction - Heartmuscle function and vitamin D

Phase 1

• Conditions: Effect of intervention with vitamin D on degree of cardiac incompensation:Degree of cardiac incompensation has been related to vitamin D deficiency and secondary hyperparathyroidism in clinical studies and cardiomyopathy in relation to vitamin D deficiency has been decribed in case-reports. Both situations reversible when the deficiency is corrected.; MedDRA version: 9.1Level: LLTClassification code 10010684Term: Congestive heart failure; MedDRA version: 9.1Level: LLTClassification code 10047626Term: Vitamin D deficiency; MedDRA version: 9.1Level: LLTClassification code 10020708Term: Hyperparathyroidism secondary

• Registration Number: EUCTR2006-005767-26-DK
• Lead Sponsor: The Department of Calcium- and Bone-metabolic Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-26
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Cardiac incompensation (patients from the clinic of cardiac incompensation from Hvidovre Hosptial)

- NYHA-class more than or equals 2
- Normal level of thyroid hormones
- Serum-level of 25-Vitamin D of less or equals 50 nmol/L
- Age above 50
- For women, postemenopausal status
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Se-calcium or PTH out of range
- Sarcoidosis or Tuberculosis
- abuse of alcohol or i.v. drugs
- pregnant or lactating
- use of vitamin D supplements
- participants in other clinical trials
- poor general health condition

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Seconday effect parameters:<br><br>Ventricular wall-thickness (Ecco)<br>Level of se-pro-BNP<br>6-min. walk test<br>Minnesota living with heart failure<br>Bloodpressure<br>Use of medication for the heart<br><br>;Primary end point(s): Heart pump function, ejection fraction by MUGA;Main Objective: Investigate the effect on degree of congestige heart failure in a group of patientens with vitamin D deficiency after 6 months intervention with vitamin D.<br><br>Primary effect parameter: Heart pumpe function, ejection fraction (%)<br>