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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005767-26-DK

Enrollment

Registered

2007-03-26

Start date

2007-05-22

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 9.1 Level: LLT Classification code 10010684 Term: Congestive heart failure MedDRA version: 9.1 Level: LLT Classification code 10

Interventions

Trade Name: Rocaltrol Pharmaceutical Form: Tablet INN or Proposed INN: calcitriol CAS Number: 32222-06 Other descriptive name: 1,25-dihydroxycholecalciferol Concentration unit: µg microgram(s) Concent

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Seconday effect parameters: Ventricular wall-thickness (Ecco) Level of se-pro-BNP 6-min. walk test Minnesota living with heart failure Bloodpressure Use of medication for the heart ;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. Primary effect parameter: Heart pumpe function, ejection fraction (%)	—

Measure

Time frame

Secondary Objective: Seconday effect parameters: Ventricular wall-thickness (Ecco) Level of se-pro-BNP 6-min. walk test Minnesota living with heart failure Bloodpressure Use of medication for the heart ;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. Primary effect parameter: Heart pumpe function, ejection fraction (%)

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026