NCT01497132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

September 10, 2014

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

December 20, 2011

Last Update Submit

September 9, 2014

Conditions

Diabetes Mellitus, Type 2Glucose IntoleranceVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Beta cell function

    Assessed by hyperglycemic clamp investigation

    8 weeks

Secondary Outcomes (3)

  • Insulin sensitivity

    8 weeks

  • Glucose tolerance

    8 weeks

  • Hypercalcemia

    8 weeks

Study Arms (2)

Vitamin D3

EXPERIMENTAL
Drug: Vitamin D3

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Vitamin D3DRUG

Oral drops 30000 IU weekly

Also known as: Vigantol oil
Vitamin D3
PlaceboDRUG

Matching placebo

Placebo

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt of Endocrinology, Karolinska University Hospital

Stockholm, Stockholm County, 17176, Sweden

Location

Related Publications (2)

  • Wagner H, Alvarsson M, Mannheimer B, Degerblad M, Ostenson CG. No Effect of High-Dose Vitamin D Treatment on beta-Cell Function, Insulin Sensitivity, or Glucose Homeostasis in Subjects With Abnormal Glucose Tolerance: A Randomized Clinical Trial. Diabetes Care. 2016 Mar;39(3):345-52. doi: 10.2337/dc15-1057. Epub 2016 Jan 19.

    PMID: 26786573DERIVED

  • Mannheimer B, Wagner H, Ostenson CG, Diczfalusy U. No impact of vitamin D on the CYP3A biomarker 4beta-hydroxycholesterol in patients with abnormal glucose regulation. PLoS One. 2015 Apr 2;10(4):e0121984. doi: 10.1371/journal.pone.0121984. eCollection 2015.

    PMID: 25835492DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose IntoleranceVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemiaAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Henrik Wagner, M.D

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 22, 2011

Study Start

January 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

September 10, 2014

Record last verified: 2014-09

Locations

SE(1)