Vitamin D deficiency/insufficiency Arterial stiffness
Conditions
Interventions
Trade Name: D3-Vicotrat
Pharmaceutical Form: Solution for injection
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Other descriptive name: D3 VICOTRAT
Concentration unit: IU international uni
Sponsors
Beaumont Hospital/RCSI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age > 65 years • Serum 25OHD levels =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Age 2.55) • LFT’s > 3 times the upper limit of normal • History of renal stones • Recent (3 months) change in medication • Hypersensitivity to cholecalciferol or any of its excipients • Hypervitaminosis D or evidence of vitamin D toxicity • Contraindications to cholecalciferol as listed in the SPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of this clinical trial is to identify whether there is evidence for changes in arterial stiffness after replacement of vitamin D in vitamin D deficient patients.;Secondary Objective: The secondary aim is to compare the efficacy of two different doses of intramuscular vitamin D in providing supplementation and whether there is a difference in their effect on arterial compliance. ;Primary end point(s): The response of pulse wave velocity to differing doses of vitamin D (Cholecalciferol 100,000IU VS 50,000IU) at 2 months. | — |
Countries
Ireland
Outcome results
None listed