Vitamin D therapy to reduce cardiovascular risk in type two diabetes - the next steps

The effect of different doses of vitamin D(3) on markers of vascular health in patients with type 2 diabetes: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50587697

Enrollment

Registered

2007-09-27

Start date

2008-06-05

Completion date

Unknown

Last updated

2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type two diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes

Interventions

Single dose of placebo, 100,000 units or 200,000 units of vitamin D3. Each patient will be followed-up for 16 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of type two diabetes mellitus.

Exclusion criteria

Exclusion criteria: 1. Taking vitamin D supplements 2. Serum 25 hydroxy vitamin D level of greater than 100 nmol/L 3. Serum creatinine greater than 200 umol/l 4. Liver function tests greater than three times the upper limit of normal 5. Hyper- or hypo-calcaemia (corrected calcium greater than 2.55 or less than 2.15 mmol/l, respectively) 6. Metastatic malignancy 7. Inability to give informed consent

Design outcomes

Primary

Measure	Time frame
Change in endothelial function measured using flow-mediated dilation of the brachial artery (added 26/02/2018: at baseline, 8 and 16 weeks after vitamin D3 treatment).	—

Secondary

Measure	Time frame
Current secondary outcomes (as of 26/02/2018): All measures are recorded at baseline, 8 and 16 weeks after vitamin D3 treatment. 1. Office blood pressure is measured using an oscillometric system 2. Brain Natriuretic Peptide is measured from a blood sample 3. Insulin sensitivity measured using Homeostasis Model Assessment (HOMA) 4. Parathyroid Hormone (PTH) is measured from a blood sample 5. Vitamin D levels are measured using the 25 hydroxy vitamin D test 6. Calcium levels are measured from a blood sample Previous secondary outcomes: Change in: 1. Office and 24-hour Blood Pressure (BP) 2. Brain Natriuretic Peptide (BNP) 3. Heart rate variability 4. Insulin sensitivity (Homeostasis Model Assessment [HOMA]) 5. Angiotensin II, renin, aldosterone 6. Parathyroid Hormone (PTH) and 25 hydroxy vitamin D levels	—

Measure

Time frame

Current secondary outcomes (as of 26/02/2018): All measures are recorded at baseline, 8 and 16 weeks after vitamin D3 treatment. 1. Office blood pressure is measured using an oscillometric system 2. Brain Natriuretic Peptide is measured from a blood sample 3. Insulin sensitivity measured using Homeostasis Model Assessment (HOMA) 4. Parathyroid Hormone (PTH) is measured from a blood sample 5. Vitamin D levels are measured using the 25 hydroxy vitamin D test 6. Calcium levels are measured from a blood sample Previous secondary outcomes: Change in: 1. Office and 24-hour Blood Pressure (BP) 2. Brain Natriuretic Peptide (BNP) 3. Heart rate variability 4. Insulin sensitivity (Homeostasis Model Assessment [HOMA]) 5. Angiotensin II, renin, aldosterone 6. Parathyroid Hormone (PTH) and 25 hydroxy vitamin D levels

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026