The effect of Vitamin D on cardiovascular risk in patients with impaired fasting glucose

Phase 1

• Conditions: Impaired fasting glycaemia; MedDRA version: 18.0 Level: LLT Classification code 10046242 Term: Unspecified vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 18.0 Level: PT Classification code 10056997 Term: Impaired fasting glucose System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2014-002766-73-GB
• Lead Sponsor: Portsmouth Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-02
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

• Individual with a diagnosis of impaired fasting glucose (fasting glucose 6.1-6.9 mmol/l as per WHO criteria)
• Age 18 to 75 years inclusive
• Participant is willing and able to give informed consent for participation in the study

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

• Established cardiovascular disease (ischaemic heart disease, cerebrovascular disease and peripheral vascular disease)
• Individuals with chronic kidney disease (stage 3B- eGFR 30-44 ml/min/1.73 m2 , stage 4- eGFR 15-29 ml/min/1.73 m2 and stage 5- eGFR <15 ml/min/1.73 m2)
• Individuals with fat malabsorption- cystic fibrosis, celiac disease, Crohn’s disease, acute or chronic pancreatitis (risk of malabsorption of Vitamin D)
• Steroids therapy (increases Vitamin D metabolism and elimination)
• On medications that can increase metabolism of vitamin D (phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampicin, non-nucleoside reverse transcriptase inhibitors used in HIV)
• Primary hyperparathyroidism
• Active granulomatous diseases including sarcoidosis and tuberculosis (increased activity of 1 alfa hydroxylase within granulomas can potentially lead to increased vitamin D toxicity)
• Allergy to vitamin D preparations, nitrates (GTN), beta2 agonists (salbutamol)
• Already taking vitamin D or calcium supplements
• On thiazide diuretics (can reduce renal excretion of calcium and increase risk of hypercalcaemia)
• On cardiac glycosides (hypercalcaemia can potentiate cardiac glycosides toxicity)
• On metformin
• Renal stones
• Peanut and soya allergy
• Pregnant and intention of becoming pregnant
• Breastfeeding
• Unable to give consent
• Participation in other clinical trials

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified