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

Condition Intervention Phase
Diabetes Mellitus, Type 2
Glucose Intolerance
Vitamin D Deficiency
Drug: Vitamin D3
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 - EVIDENS

Resource links provided by NLM:

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Beta cell function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Assessed by hyperglycemic clamp investigation

Secondary Outcome Measures:
  • 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 ]

Enrollment: 44
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D3 Drug: Vitamin D3
Oral drops 30000 IU weekly
Other Name: Vigantol oil
Placebo Comparator: Placebo Drug: Placebo
Matching placebo


Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01497132

Dpt of Endocrinology, Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Principal Investigator: Henrik Wagner, M.D Karolinska Institutet
  More Information

Responsible Party: Henrik Wagner, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01497132     History of Changes
Other Study ID Numbers: DvitamininDM2_v1_110815  2010-024487-18 
Study First Received: December 20, 2011
Last Updated: September 9, 2014
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Vitamin D Deficiency
Deficiency Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Vitamin D
Bone Density Conservation Agents
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016