Vitamin D supplementation in people at risk of type 2 diabetes
| ISRCTN | ISRCTN86515510 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86515510 |
| EudraCT/CTIS number | 2009-011264-11 |
| Secondary identifying numbers | EudraCT 2009-011264-11 |
- Submission date
- 23/10/2009
- Registration date
- 04/11/2009
- Last edited
- 03/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Graham Hitman
Scientific
Scientific
Professor of Molecular Medicine & Diabetes
Deputy Director (Research), Centre for Diabetes
Blizard Institute of Cell and Molecular Science
Barts and The London School of Medicine and Dentistry
7th Floor, John Harrison House, Whitechapel
London
E1 1BB
United Kingdom
Study information
| Study design | Randomised double-blind placebo-controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised double blind placebo controlled phase II multicentre study to investigate the effects of vitamin D2 or D3 supplementation on metabolic parameters in people at risk of type 2 diabetes |
| Study hypothesis | Current study hypothesis as of 13/02/2013: To conduct a four-month randomised controlled trial of vitamin D supplementation in people at risk of diabetes to determine whether: 1. Oral vitamin D supplementation (either vitamin D2 or vitamin D3) can lead to an improvement in glycaemia and related metabolic abnormalities in people at a high risk of developing diabetes and subsequent cardiovascular disease (CVD) compared to the placebo group 2. The feasibility and acceptability of vitamin D supplementation to inform the design of a future randomised controlled trial (RCT) with diabetes and/or cardiovascular endpoints 3. To do an exploratory analysis on the efficacy vitamin D2 as opposed to vitamin D3 Previous study hypothesis until 13/02/2013: To conduct a four-month pilot randomised controlled trial of vitamin D supplementation in people at risk of diabetes to determine whether: 1. Oral vitamin D supplementation (either vitamin D2 or vitamin D3) can lead to an improvement in glycaemia and related metabolic abnormalities in people at a high risk of developing diabetes and subsequent cardiovascular disease (CVD) compared to the placebo group 2. The feasibility and acceptability of vitamin D supplementation to inform the design of a future randomised controlled trial (RCT) with diabetes and/or cardiovascular endpoints 3. To do an exploratory analysis on the efficacy vitamin D2 as opposed to vitamin D3 |
| Ethics approval(s) | Charing Cross Research Ethics Committee ethics approval pending as of 02/11/2009; date of ethics hearing scheduled for 16/11/2009 |
| Condition | Type 2 diabetes mellitus |
| Intervention | Administration of vitamin D2 or D3. Three intervention groups: 1. Cholecalciferol: 100,000 IU once a month for 4 months 2. Ergocalciferol: 100,000 IU once a month for 4 months 3. Placebo (migyol oil): 5 ml once a month for 4 months |
| Intervention type | Supplement |
| Primary outcome measure | Glycaemia as assessed by HbA1c at last visit (4 months) |
| Secondary outcome measures | Measured at last visit (4 months): 1. Safety of oral vitamin D without a pre-assessment of vitamin D status 2. Feasibility and acceptability of the intervention 3.Quality of life and health economics (8-item short form health survey [SF8] and Euroqol instrument [EQ-5D]) and total body pain (Brief Pain Inventory [BPI]) 4. The proportion of participants with a serum 25(OH)D greater than 75 nmol/L 5. Serum 25(OH)D concentrations of 75 - 150 nmol/l measured by an LC-MS/MS (liquid chromatography-tandem mass spectrometry) assay 6. CVD risk score as assessed by UK Prospective Diabetes Study (UKPDS) risk engine 7. Fructosamine 8. Hs-CRP (high sensitivity c-reactive protein) 9. Systolic blood pressure and diastolic blood pressure 10. Random cholesterol, high density lipoprotein (HDL)-cholesterol, ApoA1 and ApoB 11. Waist circumference and body mass index (BMI) 12. Parathyroid hormone (PTH) 13. Urinary Ca:Cr (calcium:creatinine) ratio 14. Arterial stiffness assessed by pulse wave velocity (PWV) (East London participants only) 15. An exploratory analysis on the efficacy vitamin D2 as opposed to vitamin D3 |
| Overall study start date | 05/01/2010 |
| Overall study end date | 04/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 342 |
| Participant inclusion criteria | 1. Number of participants: 342 (divided between Cambridge and East London) 2. Age 30 - 75 years, either sex 3. All ethnic groups 4. People at risk of developing type two diabetes (T2D) as defined by: 4.1. The Cambridge Risk Score (CRS). The CRS cut-offs would be 0.236 for the Black/Caribbean population, 0.127 for South Asians and 0.199 for Caucasians. For other groups the cut-off for Caucasians will be used; or 4.2. Impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) defined by current World Health Organization (WHO) criteria, where this information is available in medical records, or in the records of studies in which participants have consented to being re-approached to consider participating in future studies; or 4.3. Non-diabetic hyperglycaemia as defined by HbA1c between 5.5% to 6.49%, where this information is available in medical records, or in the records of studies in which participants have consented to being re-approached to consider participating in future studies. 5. Can provide informed consent for participation in the trial |
| Participant exclusion criteria | 1. Known T2D or use of oral hypoglycaemic agents (GP records, participant history) 2. Random blood glucose during initial screening greater than 11 mmol/l (screening) 3. Known intolerance to vitamin D2 or D3 (GP records, participant history) 4. Currently taking vitamin D supplements (GP records, participant history) 5. Prior history of hypercalcaemia (serum calcium greater than 2.65 mmol/l) (GP records, participant history) or point of care ionised calcium greater than 1.3 mmol/l (screening) 6. Stage 4 or worse chronic kidney disease (estimated glomerular filtration rate [eGFR] less than 30 ml/min) (GP records, participant history) 7. History of significant liver disease (aspartate aminotransferase [AST] greater than 3 x upper limit of normal [ULN] or serum bilirubin greater than 2.5 x ULN) (GP records, participant history) 8. Past or current history of renal stones (GP records, participant history) 9. Known hyperparathyroidism (GP records, participant history) 10. Known active sarcoidosis, tuberculosis or malignancy (GP records, participant history) 11. Taking cardiac glycosides, thiazide diuretics or corticosteroids in the past one month (GP records, participant history) 12. Documented anaemia of less than 11 g% or known haemoglobinopathy such as sickle cell anaemia and beta or alpha thalassemia (GP records, participant history) 13. Planned travel out of the London area or Cambridge (depending of site of recruitment) within 8 weeks of enrolment such that it will disrupt monitoring of the participant (participant history) 14. Breast feeding, pregnancy or planning a pregnancy (participant history) |
| Recruitment start date | 05/01/2010 |
| Recruitment end date | 04/01/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Barts and The London School of Medicine and Dentistry
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Sponsor information
Queen Mary University of London/Barts and The London NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Joint R&D office
Queen Mary's Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2AT
England
United Kingdom
| Website | http://www.qmul.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Government
NHS Tower Hamlets and MRC Epidemiology Centre (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/10/2013 | Yes | No | |
| Results article | results | 01/04/2016 | Yes | No |
Editorial Notes
03/10/2018: Publication reference added.
Please note that until 13/02/2013, the scientific title was "A randomised double blind placebo controlled phase II multicentre pilot study to investigate the effects of vitamin D2 or D3 supplementation on metabolic parameters in people at risk of type 2 diabetes"
