Prospective, placebo-controlled trial of vitamin D supplementation in patients with low-levels of 25-OH vitamin D to evaluate changes in markers of cardiovascular risk

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007474-33-AT

Enrollment

100

Registered

2008-04-28

Start date

2008-06-12

Completion date

Unknown

Last updated

2016-11-07

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

Conditions

low levels of 25-OH vitamin D

Interventions

Trade Name: Oleovit D3 Product Name: OLEOVIT D3 Pharmaceutical Form: Oral drops* INN or Proposed INN: colecalciferol Current Sponsor code: 10.989 Concentration unit: IU/ml international unit(s)/millil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 25(OH)D level =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Heart failure > NYHA II previous cardiovascular events Serum Creatinine > 1.5 mg/dl AST / ALT > 3x ULN diabetes mellitus uncontrolled hypertension (RR>160/100, either or) new onset of statins or ACE-I or ARBs (within the last 2 month) hypercalcaemia urolithiasis major psychiatric disorder

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the association between 25(OH)D levels and cardiovascular risk expressed by two surrogate markers for such risk: CFU-Hill count as a Biomarker and endothelial function. Furthermore patients with low 25(OH)D levels will be supplemented to investigate whether such an intervention will influence CFU-Hill count, endothelial function and cardiovascular risk.;Secondary Objective: ;Primary end point(s): Changes in CFU-Hill counts by vitamin D supplementation. Changes in endothelial function by vitamin D supplementation	—

Measure

Time frame

Main Objective: To investigate the association between 25(OH)D levels and cardiovascular risk expressed by two surrogate markers for such risk: CFU-Hill count as a Biomarker and endothelial function. Furthermore patients with low 25(OH)D levels will be supplemented to investigate whether such an intervention will influence CFU-Hill count, endothelial function and cardiovascular risk.;Secondary Objective: ;Primary end point(s): Changes in CFU-Hill counts by vitamin D supplementation. Changes in endothelial function by vitamin D supplementation

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Countries

Austria

Outcome results

None listed

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