Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 (EVIDENS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henrik Wagner, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01497132
First received: December 20, 2011
Last updated: September 9, 2014
Last verified: September 2014

December 20, 2011
September 9, 2014
January 2012
May 2013   (final data collection date for primary outcome measure)
Beta cell function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Assessed by hyperglycemic clamp investigation
Same as current
Complete list of historical versions of study NCT01497132 on ClinicalTrials.gov Archive Site
  • Insulin sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Assessed by hyperglycemic clamp investigation
  • Glucose tolerance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Assessed by OGTT
  • Hypercalcemia [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2
Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 - EVIDENS

The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Glucose Intolerance
  • Vitamin D Deficiency
  • Drug: Vitamin D3
    Oral drops 30000 IU weekly
    Other Name: Vigantol oil
  • Drug: Placebo
    Matching placebo
  • Experimental: Vitamin D3
    Intervention: Drug: Vitamin D3
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at OGTT.
  • BMI ≤ 32 kg/m2.
  • HbA1c ≤ 7.0 % (MonoS) or ≤ 63 mmol/mol (IFCC).
  • Fasting plasma glucose < 9 mmol/l
  • S-25-OH-vitamin D3 < 75 nmol/l.

Exclusion Criteria:

  • Treatment with any vitamin D preparation.
  • Regular sun-bathing in solarium.
  • Hypercalcemia at screening, defined as free s-calcium > 1.35 mmol/l.
  • Hyperphosphatemia at screening, defined as s-phosphate > 1.5 mmol/l.
  • Sarcoidosis or other granulomatous disease.
  • Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.
  • Impaired hepatic function.
  • Impaired renal function
  • Cardiac disease defined as:

    • Unstable angina pectoris
    • Myocardial infarction within the last 6 months
    • Congestive heart failure NYHA class III and IV
  • Cerebral stroke within the last 6 months.
  • Anti-diabetic medication of any kind.
  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
Both
45 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01497132
DvitamininDM2_v1_110815, 2010-024487-18
No
Henrik Wagner, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Henrik Wagner, M.D Karolinska Institutet
Karolinska Institutet
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP