NCT00960635

Brief Summary

This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the daily intake of 1,25-dihydroxy-vitamin D3 \[1,25(OH)2D3\], improves beta cell function in patients with recently diagnosed type 1 diabetes. The treatment consists of the daily oral administration of 0.25 µg 1,25(OH)2D3 or placebo for 9 months and an equal follow-up time without supplementation. Fasting, peak and AUC C-peptide concentrations during a 2-hour mixed meal tolerance test are measured at the beginning of the study, as well as at the end of the treatment and the follow-up period in month 9 and 18. The null hypothesis is that there is no difference between 1,25(OH)2D3 treated subjects and the placebo group in the AUC C-peptide at month 18.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_2

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

June 1, 2001

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
Last Updated

August 18, 2009

Status Verified

August 1, 2009

Enrollment Period

7.2 years

First QC Date

August 17, 2009

Last Update Submit

August 17, 2009

Conditions

Type 1 Diabetes

Keywords

new-onset

Study Arms (2)

calcitriol

ACTIVE COMPARATOR
Drug: 1,25-dihydroxy-vitamin D3 (calcitriol)

pill without agent

PLACEBO COMPARATOR
Drug: placebo

Interventions

1,25-dihydroxy-vitamin D3 (calcitriol)DRUG
calcitriol
placeboDRUG

pill without agent

pill without agent

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • New onset Typ 1 diabetes (\< 6 weeks insulin therapy)
  • Age 18-39 years
  • GADA and/or IA-2A positive

You may not qualify if:

  • Kidney disease
  • Pregnancy
  • Lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut fuer Diabetesforschung

Munich, 80804, Germany

Location

Related Publications (1)

  • Walter M, Kaupper T, Adler K, Foersch J, Bonifacio E, Ziegler AG. No effect of the 1alpha,25-dihydroxyvitamin D3 on beta-cell residual function and insulin requirement in adults with new-onset type 1 diabetes. Diabetes Care. 2010 Jul;33(7):1443-8. doi: 10.2337/dc09-2297. Epub 2010 Mar 31.

    PMID: 20357369DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Anette G Ziegler, MD

    Institut fuer Diabetesforschung

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 18, 2009

Study Start

June 1, 2001

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 18, 2009

Record last verified: 2009-08

Locations

DE(1)