Vitamin D DeficiencyPhase 3NCT00968877
Vitamin D and Chronic Renal Insufficiency
A Phase 3 study testing Cholecalciferol in people with Vitamin D Deficiency and Chronic Renal Insufficiency, run by Odense University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency, Chronic Renal Insufficiency
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Jan 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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.
Read the detailed description
Most patients with chronic renal insufficiency have vitamin D deficiency. It is still not common practice among nephrologists to monitor and correct vitamin D deficiency of chronic kidney disease (CKD) patients, because it is widely believed that any vitamin D deficiency associated with calcium-phosphate disturbances is better treated with activated vitamin D.
However, correction of vitamin D deficiency with native vitamin D seems to have numerous favorable effects not only related to the renal and intestinal handling of calcium and phosphate. It may have beneficial effects on bone and vascular health, the immune system and physical performance that are not obtained with active vitamin D treatment.
We are therefore planning a randomized, placebo-controlled, intervention study of 8 weeks' duration in which vitamin D3 supplementation (40 000 IE per week in one capsule) is compared with placebo in a trial including 120 CKD patients with vitamin D deficiency. Multiple biological variables are monitored in order to assess any effect on the biological systems of interest.
- Conditions
- Vitamin D Deficiency, Chronic Renal Insufficiency
- Being tested
- Cholecalciferol
- Keywords
- Renal Insufficiency, Cholecalciferol, Kidney Disease, Kidney Failure, Vitamin D, Vitamin D Deficiency, Vitamin D3
- Medical subject headings
- Vitamin D Deficiency, Renal Insufficiency, Chronic, Renal Insufficiency, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Dekristol
capsule 40 000 IU (p.o.) once per week, in 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Active comparator | Not described Receives: Drug: Cholecalciferol |
| Placebo | Placebo comparator | Not described Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test
Measured: 8 weeks
Secondary outcomes (1)
Health questionnaire
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Peter Marckmann, Prof, DMSc, Study director, Nephrological department, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968877
- Sponsor's protocol ID
- Vita-D3
- Status last verified
- Dec 2009
- First submitted
- 28 Aug 2009
- Last updated
- 26 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Chronic Renal Insufficiency
- ClinicalTrials.gov ID
- NCT00968877
- Acronym / sponsor ID
- Vita-D3
- Conditions
- Vitamin D Deficiency, Chronic Renal Insufficiency
- Keywords
- Renal Insufficiency, Cholecalciferol, Kidney Disease, Kidney Failure, Vitamin D, Vitamin D Deficiency, Vitamin D3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 31 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Most patients with chronic renal insufficiency have vitamin D deficiency. It is still not common practice among nephrologists to monitor and correct vitamin D deficiency of chronic kidney disease (CKD) patients, because it is widely believed that any vitamin D deficiency associated with calcium-phosphate disturbances is better treated with activated vitamin D.
However, correction of vitamin D deficiency with native vitamin D seems to have numerous favorable effects not only related to the renal and intestinal handling of calcium and phosphate. It may have beneficial effects on bone and vascular health, the immune system and physical performance that are not obtained with active vitamin D treatment.
We are therefore planning a randomized, placebo-controlled, intervention study of 8 weeks' duration in which vitamin D3 supplementation (40 000 IE per week in one capsule) is compared with placebo in a trial including 120 CKD patients with vitamin D deficiency. Multiple biological variables are monitored in order to assess any effect on the biological systems of interest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol | Active comparator | Drug: Cholecalciferol |
| Placebo | Placebo comparator | Drug: Cholecalciferol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolAlso: Dekristolcapsule 40 000 IU (p.o.) once per week, in 8 weeks. | Drug | Cholecalciferol, Placebo |
Primary outcome
Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test
Time frame: 8 weeks
1 secondary outcome
Health questionnaire
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2011.
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Strategies for Proactive Health in People With Kidney Function Decline
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Preeclampsia Research on Vitamin D, Inflammation, & Depression
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Marckmann, Prof, DMSc study director
Nephrological department, Odense University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cholecalciferol in people with Vitamin D Deficiency and Chronic Renal Insufficiency, run by Odense University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2011; AzTrials last refreshed its copy on 1 Nov 2026.