NCT00812578

Brief Summary

The purpose of the study is to examine the effect on metabolic parameters after 12 weeks of treatment with high dose vitamin D in patients with type 2 diabetes and vitamin D insufficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2 type-2-diabetes

Timeline
Completed

Started Dec 2008

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

Study Start

First participant enrolled

December 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 12, 2010

Status Verified

July 1, 2010

Enrollment Period

1.5 years

First QC Date

December 19, 2008

Last Update Submit

July 9, 2010

Conditions

Type 2 DiabetesVitamin D Insufficiency

Keywords

Type 2 diabetesVitamin D insufficiencyInsulin secretionInsulin sensitivityPulsatility

Outcome Measures

Primary Outcomes (1)

  • Insulin secretion and insulin resistance

    6 hours

Secondary Outcomes (1)

  • Glycemic control, lipid status, inflammatory markers, BMD

    2 months

Study Arms (2)

Cholecalciferol

ACTIVE COMPARATOR
Drug: Cholecalciferol

Placebo pill

PLACEBO COMPARATOR
Drug: Cholecalciferol

Interventions

CholecalciferolDRUG

8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks

CholecalciferolPlacebo pill

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Type 2 diabetes
  • Patients of Danish extraction
  • Vitamin D insufficiency (1,25OHvitD \< 50 nmol/l)

You may not qualify if:

  • Nephropathy (Urea \> 12 mmol/l)
  • S-calcium \> 2,52 mmol/L
  • Primary hyperparathyroidism
  • Serious disease
  • Malabsorption
  • Sarcoidosis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Unit, Medical Department M, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Kampmann U, Mosekilde L, Juhl C, Moller N, Christensen B, Rejnmark L, Wamberg L, Orskov L. Effects of 12 weeks high dose vitamin D3 treatment on insulin sensitivity, beta cell function, and metabolic markers in patients with type 2 diabetes and vitamin D insufficiency - a double-blind, randomized, placebo-controlled trial. Metabolism. 2014 Sep;63(9):1115-24. doi: 10.1016/j.metabol.2014.06.008. Epub 2014 Jun 19.

    PMID: 25044176DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Lotte Oeskov, MD

    Medical Department, Silkeborg Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

December 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 12, 2010

Record last verified: 2010-07

Locations

DK(1)