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Vitamin D therapy to reduce cardiovascular risk in Type 2 diabetes – the next steps

Vitamin D therapy to reduce cardiovascular risk in Type 2 diabetes – the next steps

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003767-51-GB
Enrollment
Unknown
Registered
2007-11-26
Start date
2008-01-23
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Interventions

Sponsors

Research and Innovation Services, University of Dundee
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Diagnosis of type 2 diabetes mellitus 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: - Taking vitamin D supplements - Serum 25 hydroxy vitamin D level of >100nmolL - Serum creatinine >200umol/l - Liver function tests >3 times the upper limit of normal - Hyper or hypocalcaemia (corrected calcium >2.55 or <2.15mmol/l, respectively) - History of sarcoidosis - History of renal calculi - Metastatic malignancy - Inability to give informed consent.

Design outcomes

Primary

MeasureTime frame
Main Objective: To test whether higher doses of vitamin D3 improve blood pressure and vascular function more than lower doses of vitamin D3;Secondary Objective: To test whether patients with normal baseline vitamin D levels benefit from supplementation as much as those with low baseline vitamin D levels To test whether patients receiving supplementation in summer benefit as much as those receiving supplementation in winter;Primary end point(s): Change in endothelial function as measured by flow mediated dilatation of the brachial artery

Countries

United Kingdom

Outcome results

None listed

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