Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/10/2009
Date assigned
04/11/2009
Last edited
29/10/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.mrc-epid.cam.ac.uk/Research/Studies/VitaminD/index.html

Contact information

Type

Scientific

Primary contact

Prof Graham Hitman

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2009-011264-11

ClinicalTrials.gov number

Protocol/serial number

EudraCT 2009-011264-11

Study information

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

Acronym

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

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"

Ethics approval

Charing Cross Research Ethics Committee ethics approval pending as of 02/11/2009; date of ethics hearing scheduled for 16/11/2009.

Study design

Randomised double-blind placebo-controlled multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Vitamin D2 or D3

Primary outcome measures

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 trial start date

05/01/2010

Overall trial end date

04/01/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

342

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

United Kingdom

Trial participating centre

Professor of Molecular Medicine & Diabetes
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Queen Mary University of London/Barts and The London NHS Trust (UK)

Sponsor details

Joint R&D office
Queen Mary's Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2AT
United Kingdom

Sponsor type

Government

Website

http://www.qmul.ac.uk/

Funders

Funder type

Government

Funder name

NHS Tower Hamlets and MRC Epidemiology Centre (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24152375

Publication citations

  1. Protocol

    Menon RK, Rickard AP, Mannan N, Timms PM, Sharp SJ, Martineau A, Boucher BJ, Chowdhury TA, Griffiths CJ, Griffin SJ, Hitman GA, Forouhi NG, The effects of vitamin D₂ or D₃ supplementation on glycaemic control and related metabolic parameters in people at risk of type 2 diabetes: protocol of a randomised double-blind placebo-controlled trial., BMC Public Health, 2013, 13, 999, doi: 10.1186/1471-2458-13-999.

Additional files

Editorial Notes