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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01497132

Acronym

EVIDENS

Enrollment

Registered

2011-12-22

Start date

2012-01-31

Completion date

2013-05-31

Last updated

2014-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Glucose Intolerance, Vitamin D Deficiency

Brief summary

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.

Interventions

DRUGVitamin D3

Oral drops 30000 IU weekly

DRUGPlacebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Beta cell function	8 weeks	Assessed by hyperglycemic clamp investigation

Secondary

Measure	Time frame	Description
Insulin sensitivity	8 weeks	Assessed by hyperglycemic clamp investigation
Glucose tolerance	8 weeks	Assessed by OGTT
Hypercalcemia	8 weeks	—

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026