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

NCT ID: NCT01585051

Last Updated: 2012-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-06-30

Brief Summary

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

Conditions

Diabetes Mellitus Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

vitamin D

Intervention: Intramuscular injection of 300 000 U of 25(OH)vitamin D

Group Type: ACTIVE_COMPARATOR

25(OH) vitamin D

Intervention Type: DRUG

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.

placebo

administration of 0.9 % NaCl as a placebo

Group Type: PLACEBO_COMPARATOR

0.9 % NaCl

Intervention Type: DRUG

1 ml of 0.9 % of NaCl at the beginning and 0.5 ml of 0.9 % NaCl after three months

Interventions

25(OH) vitamin D

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.

Intervention Type: DRUG

0.9 % NaCl

1 ml of 0.9 % of NaCl at the beginning and 0.5 ml of 0.9 % NaCl after three months

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kantonsspital Baselland Bruderholz

OTHER

Sponsor Role: lead

Responsible Party

Reto Krapf

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reto Krapf, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Kantonsspital Bruderholz, University of Basel, Switzerland

Locations

Department of medicine, Kantonsspital Bruderholz

Bruderholz/Basel, Basel-Landschaft, Switzerland

Countries

Switzerland

References

Jehle S, Lardi A, Felix B, Hulter HN, Stettler C, Krapf R. Effect of large doses of parenteral vitamin D on glycaemic control and calcium/phosphate metabolism in patients with stable type 2 diabetes mellitus: a randomised, placebo-controlled, prospective pilot study. Swiss Med Wkly. 2014 Mar 20;144:w13942. doi: 10.4414/smw.2014.13942.

Reference Type: DERIVED

PMID: 24652692 (View on PubMed)

Other Identifiers

x335/08

Identifier Type: -

Identifier Source: org_study_id