E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Randomised, placebo controlled, parallel group, double blinded study to investigate if oral supplementation of vitamin D will improve cardiovascular function and metabolic and inflammatory parameters in South Asian women. Will investigate endothelial function in the south asian women. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10047066 |
E.1.2 | Term | Vascular disorders NEC |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
That oral supplementation of vitamin D will improve cardiovascular function and metabolic and inflammatory parameters in South Asian women.
|
|
E.2.2 | Secondary objectives of the trial |
Microvascular endothelial function will be tested using Iontophoresis according to standard guidelines Change in arterial stiffness as measured by pulse wave velocity using the validated SphygmoCor pulse waveform analysis system Change in office blood pressure measured by oscillometric automatic blood pressure device Change in metabolic and inflammatory markers:
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age ≥ 18 years Female Serum 25 hydroxyvitamin D <75nmol/L South Asian ethnicity, as defined by the participant
|
|
E.4 | Principal exclusion criteria |
Symptomatic Cardiovascular Disease (including previous stroke, TIA, angina, myocardial infarction, angioplasty, coronary bypass grafting, symptomatic peripheral vascular disease, chronic heart failure, atrial fibrillation)
Already taking vitamin D supplements. Consumption of fish oils will not be a contraindication to enrolment as the vitamin D content is very low relative to the dose used in the study.
Estimated glomerular filtration rate <40ml/min (by 4 variable MDRD equation)
Liver function tests (ALT, Bilirubin, Alkaline phosphatase) >3x normal. These two criteria will ensure that sufficient renal and hepatic function is available to convert vitamin D to the active 1,25 hydroxy form.
Unable to give written informed consent
Corrected calcium level of >2.60 or <2.15 mmol/L
Clinical diagnosis of osteomalacia
History of renal calculi, sarcoidosis or metastatic malignancy. Excluding these groups will minimise the risk of side effects from vitamin D supplementation.
Pregnant or of child bearing age and not taking reliable contraception.
Anyone who is pregnant is excluded from taking part in this study. Therefore if the subject is of childbearing potential and there is a possibility that they may be preganant, we will require to catty out a preganancy test beforehand.
|
|
E.5 End points |
E.5.1 | Primary end point(s) | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |