Systemic Lupus ErythematosusPhase 1NCT00418587
Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
A Phase 1 study testing Cholecalciferol in people with Systemic Lupus Erythematosus, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to test the safety and effectiveness of different doses of vitamin D in patients with Systemic Lupus Erythematosus (SLE). A long term goal is to determine if vitamin D could be used as a treatment and/or preventative of SLE. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Aug 2014
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SLE by ACR criteria (revised 1997)
- African American, participating in the SLE in Gullah Health (SLEIGH) Study
- Outpatient
- Stable disease with no BILAG A or B in any system for the past 4 weeks
- Stable prednisone (or equivalent corticosteroid) dose ≤ 20 mg/day for ≥ 4 weeks prior to study entry
- Baseline 25(OH)D concentration of < 30 ng/ml
Show all 10Show fewer
- Willingness to discontinue other vitamin D supplements and/or multivitamins containing vitamin D while participating in the study
- Age 18 - 85 years
- Ability to complete questionnaires in English
- Ability to give informed consent
Who cannot join
- Presence of hypercalcemia (>10.4 mg/dL), hypercalcuria (urinary calcium/creatinine ratio ≥ 0.8 mmol/mmol) or known primary hyperparathyroidism
- Liver disease (serum ALT, AST >2x normal) or total serum bilirubin >1.5x normal
- History of renal stones
- Current treatment with any dose of cyclophosphamide
- Dialysis or creatinine > 2.5 mg/dL
- Pregnancy
- Current drug or alcohol abuse
- Anticipated poor compliance
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to test the safety and effectiveness of different doses of vitamin D in patients with Systemic Lupus Erythematosus (SLE). A long term goal is to determine if vitamin D could be used as a treatment and/or preventative of SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Cholecalciferol
- Keywords
- Vitamin D, Lupus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Vitamin D3
800 IU oral daily
CholecalciferolDrug
Also called Vitamin D3
2000 IU oral daily
CholecalciferolDrug
Also called Vitamin D3
4000 IU oral daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 800 IU oral daily dose level Receives: Drug: Cholecalciferol |
| 2 | Experimental | 2000 IU oral daily dose level Receives: Drug: Cholecalciferol |
| 3 | Experimental | 4000 IU oral daily dose level Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypercalcuria
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionAug 2008
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Rheumatology Research and Education Foundation, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Diane L Kamen, MD, MSCR, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418587
- Sponsor's protocol ID
- MUSC-GAC734-HR16356
- Status last verified
- Aug 2016
- First submitted
- 4 Jan 2007
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT00418587
- Acronym / sponsor ID
- MUSC-GAC734-HR16356
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Vitamin D, Lupus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- American College of Rheumatology Research and Education Foundation, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Dec 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Jan 2007 (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.
The purpose of this study is to test the safety and effectiveness of different doses of vitamin D in patients with Systemic Lupus Erythematosus (SLE). A long term goal is to determine if vitamin D could be used as a treatment and/or preventative of SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cholecalciferol800 IU oral daily dose level |
| 2 | Experimental | Drug: Cholecalciferol2000 IU oral daily dose level |
| 3 | Experimental | Drug: Cholecalciferol4000 IU oral daily dose level |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- SLE by ACR criteria (revised 1997)
- African American, participating in the SLE in Gullah Health (SLEIGH) Study
- Outpatient
- Stable disease with no BILAG A or B in any system for the past 4 weeks
- Stable prednisone (or equivalent corticosteroid) dose ≤ 20 mg/day for ≥ 4 weeks prior to study entry
Key exclusion criteria (8 listed)
- Presence of hypercalcemia (>10.4 mg/dL), hypercalcuria (urinary calcium/creatinine ratio ≥ 0.8 mmol/mmol) or known primary hyperparathyroidism
- Liver disease (serum ALT, AST >2x normal) or total serum bilirubin >1.5x normal
- History of renal stones
- Current treatment with any dose of cyclophosphamide
- Dialysis or creatinine > 2.5 mg/dL
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: Vitamin D3800 IU oral daily | Drug | 1 |
| CholecalciferolAlso: Vitamin D32000 IU oral daily | Drug | 2 |
| CholecalciferolAlso: Vitamin D34000 IU oral daily | Drug | 3 |
Primary outcome
Hypercalcuria
Time frame: Monthly
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 18 Jun 2018.
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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.
Diane L Kamen, MD, MSCR principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cholecalciferol in people with Systemic Lupus Erythematosus, run by Medical University of South Carolina at 1 site in United States.
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 10 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 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Hypercalcuria (time frame: Monthly). 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 18 Jun 2018.