Vitamin D Deficiency Clinical Trial
Official title:
Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2 and Low 25(OH)D Concentrations: Does it Help to Improve Endothelial Function-The DIMENSION TRIAL
Background and Objectives :
The presence of vitamin D deficiency in patients with type 2 diabetes mellitus (T2DM) is
associated with an increased risk of cardiovascular disease (CVD). We aim to see whether
supplementation of vitamin D in these patients helps to improve the endothelial function
(EF) a surrogate marker of CVD risk.
Hypothesis: Vitamin D supplementation in patients with T2DM and low serum 25(OH) D
concentrations (<30ng/ml) will improve EF as measured by the Endo-PAT machine by 0.4 units
(30% improvement over baseline) and/or will result in a increase of EPCs (CD133+/KDR+) and
CD45dim CD34+/KDR.
The investigators will test this hypothesis by comparing 2 groups of T2DM patients
randomized to placebo or vitamin D3 for 16 weeks.
Methods:
This is a 16 weeks trial in which 120 T2DM patients will be screened with the aim to recruit
60 T2DM patients with vitamin D deficiency or insufficiency. Out of these 60 patients , 30
patients will be started on vitamin D supplementation and 30 patients will be given a
matched placebo. Endothelial function (EF) will be checked before and after supplementation
to see a change in EF.
Significance of Project:
If this study shows a significant improvement of EF, it would justify larger scale studies
to show that vitamin D supplementation in patients with T2DM mitigates CVD risk and vitamin
D supplementation in patients with T2DM and vitamin D deficiency to improve CVD risk.
Overall Aims: Type 2 Diabetes Mellitus (T2DM) is increasingly more prevalent in Singapore
and is a high cardiovascular diseases (CVD) risk factor (1,2). The presence of low serum
25(OH)D concentrations (<30ng/ml) has also been classified as an independent predictor of
CVD(3,4) and has been seen to be more prevalent in T2DM (5-7). We aim to see whether
replacement with vitamin D in these patients helps to mitigate CVD risk. Since endothelial
dysfunction is one of the earliest manifestations of CVD and is a very robust surrogate
marker, we aim to measure the endothelial function (EF) before and after vitamin D
supplementation to evaluate for beneficial impact on this endpoint.
Specific Aims: Although, there are some small scale studies done with a single high dose
replacement of vitamin D2/D3, no studies have been done using regular daily supplementation
with vitamin D3 and with measurement of EF using the Endo-PAT machine or measurement of
endothelial progenitor cells (EPCs).We are doing this pilot study to see whether replacement
with vitamin D results in an improvement of EF as measured using the Endo-PAT and estimation
of EPCs and some biomarkers as independent established surrogate markers of CVD risk. The
estimation of endothelial progenitor cells has been proposed as a surrogate marker of
vascular dysfunction and is known to be reduced in patients with cardiovascular risk factors
(8). The no. of circulating endothelial cells (CECs) and endothelial microparticles have
been seen to be elevated in patients with cardiovascular risk factors and DM and has also
been proposed as a effective surrogate marker. We aim to quantify the no. of endothelial
progenitor cells (EPCs) staining positive for CD133+/KDR (kinase insert domain-containing
receptor),CD34+/KDR and CD45dim CD34+/KDR , CECs (CD 146+/CD45- ) and EMPs derived from
endothelial progenitors (CD45−/CD146+/CD34+/CD117+) and from mature endothelial cells
(CD45−/CD146+/CD34+/CD117−).using flow cytometry.
Primary Hypothesis:
Vitamin D supplementation in patients with T2DM and low serum 25(OH) D concentrations
(<30ng/ml) will improve EF as measured by the Endo-PAT machine by 0.4 units (30% improvement
over baseline) and/or will result in a increase of EPCs (CD133+/KDR+) and CD45dim CD34+/KDR.
The investigators will test this hypothesis by comparing 2 groups of T2DM patients
randomized to placebo or vitamin D3 for 16 weeks.
Secondary Objectives:
To explore the prevalence of low serum 25(OH) D concentrations (<30ng/ml) in T2DM patients
and evaluate the difference in the EF in the two groups. To see whether vitamin D
supplementation helps to further improve other parameters such as biomarkers, blood
pressure, BMI, urine albumin-to-creatinine ratio (ACR), lipid profile of T2DM patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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