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Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity

NCT00992797 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-11-03

No results posted yet for this study

Summary

The aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from supplementation with cholecalciferol in sufficient doses to optimize serum levels.

Conditions

  • Diabetes Mellitus Type 2
  • Hypovitaminosis D

Interventions

DRUG

Cholecalciferol

Cholecalciferol 200.000 IU pr ampoule, 400.000 IU given at randomization day, followed by additionally 200.000 IU at week 5 if serum 25(OH)D \< 100 nmol/L. If serum 25(OH)D \> 100 placebo will be given. The cholecalciferol will be given in orange juice.

OTHER

Orange juice

Orange juice at randomization day and at week 5.

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • University Hospital, Aker

    lead OTHER

Principal Investigators

  • Kåre I Birkeland, MD PhD · Oslo University Hospital, Aker

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-12-31
Completion
2011-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00992797 on ClinicalTrials.gov