Effect of Vitamin D Supplementation on Blood Pressure and HbA1c Levels in Patients With T2D

Study Overview
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Brief Summary
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The effect of administration of vitamin D is tested on the long-term control of blood sugar (as measured by HbA1-c levels in blood) and mean blood pressure (as measured by 24 hour blood pressure profiles)in patients with stable type 2 diabetes mellitus

Official Title
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Effect of Administration of 25(OH) Vitamin on Mean 24 Hour Blood Pressure and HBA1c Levels in Patients With Stable Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: 25(OH) vitamin D
* Drug: 0.9 % NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Men and women, ages ≥18 years Official diagnostic criteria for type 2 diabetes fulfilled in patients on any type of oral or parenteral glucose-lowering treatment Independent living at home On stable regimen of BP meds (if any) with BP well controlled and/or K supplement (if any) for 2 months and which is deemed unlikely to change during the study Stable glucose control for 2 months by any approved method including insulin Exclusion criteria Patients with type 1 diabetes (or insulin-requiring diabetes of unclear type) Patients on hemodialysis, with hyperparathyroidism or active cancer disease Patients with known metabolic bone disease Laboratory evidence of kidney (eGFR < 60 ml/min) or liver disease Dietary calcium intake exceeding 1500mg/d (as estimated by dietary history) 25(OH) vitamin D levels at baseline > 70 nmol/L Calciuria (> 8 mmol/24 hours as measured by 24 hour urine collections) Hypo- and hypercalcemias and hypo- and hyperphosphatemias of any cause Medications that affect vitamin D metabolism (e.g. antiepileptic drugs, calcimimetics, 1-34 PTH (Forsteo) vitamin D therapy over and above 400U daily 6 months prior to enrollment and during the study) Foreseeable need for adaptation of either glucose- or blood pressure lowering during the next 6 months as decided by the family physician or the treating diabetologist - see above History of binge eating or wt gain or loss exceeding 6 kg in past 18 months Patients on any type of inhibitors of plasma coagulation (i.e. coumarine, heparins)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitamin D<br>Intervention: Intramuscular injection of 300 000 U of 25(OH)vitamin D | Drug: 25(OH) vitamin D<br>* 300 000 U intramuscularly, one dosage, in subjects with 25 (OH) vit D levels below 80 nmol/L, another dosage of 150 000 U after 3 months if 25(OH)vit D levels continue to be below 80 nmol/L.<br>|
| Placebo Comparator: placebo<br>administration of 0.9 % NaCl as a placebo | Drug: 0.9 % NaCl<br>* 1 ml of 0.9 % of NaCl at the beginning and 0.5 ml of 0.9 % NaCl after three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HBA1-c levels |  | 3 and 6 months | 
| 24 hour mean blood pressure |  | 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma glucose |  | 3 and 6 months | 
| HOMA |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, blood pressure, typ 2 diabetes mellitus, blood glucose, HbA1c