NCT00968877

Brief Summary

Purpose of this study is to investigate the effect of treatment with vitamin D3 (cholecalciferol) compared with placebo in a trial including chronic kidney disease patients with vitamin D deficiency.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_3

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 26, 2011

Status Verified

December 1, 2009

Enrollment Period

3 months

First QC Date

August 28, 2009

Last Update Submit

January 25, 2011

Conditions

Vitamin D DeficiencyChronic Renal Insufficiency

Keywords

Renal InsufficiencyCholecalciferolKidney DiseaseKidney FailureVitamin DVitamin D DeficiencyVitamin D3

Outcome Measures

Primary Outcomes (1)

  • Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test

    8 weeks

Secondary Outcomes (1)

  • Health questionnaire

    8 weeks

Study Arms (2)

Cholecalciferol

ACTIVE COMPARATOR
Drug: Cholecalciferol

Placebo

PLACEBO COMPARATOR
Drug: Cholecalciferol

Interventions

CholecalciferolDRUG

capsule 40 000 IU (p.o.) once per week, in 8 weeks.

Also known as: Dekristol
CholecalciferolPlacebo

Eligibility Criteria

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

You may qualify if:

  • Chronic kidney disease (CKD 3-5 amd renal transplanted patients)
  • Age \> 18 years
  • Vitamin D insufficiency or deficiency (25-OHD \< 50 nmol/l, 3 months before project start)

You may not qualify if:

  • Treatment with vitamin D2/D3 (dose more than 10000 IU within the last 3 months)
  • Hypercalcaemia (ca++ \> 1,35 mmol/l more than 4 weeks despite missing intake of calcium containing preparations and activated vitamin D)
  • Uncontrolled hyperphosphataemia (s-phosphate \> 2,2 mmol/l)
  • Sarcoidosis
  • Malignant disease
  • Psychotic disorders
  • Pregnancy and lactation women
  • Allergy to soya and peanut

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitamin D DeficiencyRenal Insufficiency, ChronicRenal InsufficiencyKidney Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Peter Marckmann, Prof, DMSc

    Nephrological department, Odense University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2011

Last Updated

January 26, 2011

Record last verified: 2009-12