Vitamin D DeficiencyVITALUPNCT01413230
Vitamin D Supplementation in Systemic Lupus Erythematosus
An observational study of Vitamin D Deficiency, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the skin, the joints, the nervous system and the kidney and may be life threatening. SLE is associated with production of autoantibodies and perturbations in regulatory T cells and T helper lymphocytes producing interleukin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- cholecalciferol
- How many people
- 20 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2010to Jan 2011
- Phase
- Observational
- 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
Study population: Patient with SLE
Who may be able to join
- Systemic lupus erythematosus
- Age > 18 years
- Serum vitamin D levels [25(OH)D] < 30 ng/mL
- Low to moderate active disease without modification of associated treatments
Who cannot join
- Pregnancy
- Serum 25(OH)D levels > 30 ng/mL
- Flare requiring modification of treatments
Trial locations and contacts
3 sites in 1 country.
France3 sites
Chu Pitie Salpetriere
Paris, 75013
Hopital la Pitie Salpétrière
Paris, 75013
Nathalie Costedoat-Chalumeau
Paris, 75013
About this study
Official title: Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the skin, the joints, the nervous system and the kidney and may be life threatening.
SLE is associated with production of autoantibodies and perturbations in regulatory T cells and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).
Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.
Immunomodulatory effects of vitamin D supplementation in VITRO was recently described, notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and CD8+ T cells and the decrease of Th17 cells.
Read the detailed description
Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the skin, the joints, the nervous system and the kidney and may be life threatening.
SLE is associated with production of autoantibodies and perturbations in regulatory T cells and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).
Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.
Immunomodulatory effects of vitamin D supplementation in VITRO was recently described, notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and CD8+ T cells and the decrease of Th17 cells.
Objective : To evaluate the cellular immune response after vitamin D supplementation in patients with SLE.
Methods : This is an open prospective trial. SLE patients with hypovitaminosis D (< 30 ng/mL) receive vitamin D supplementation. 100 000 UI of cholecalciferol per week for 4 weeks then 100 000 UI of cholecalciferol per month for 6 months will be administered. All patients are followed after the beginning of vitamin D supplementation at month 2 and month 6.
End points :
- Clinical and biological tolerance: Absence of hypercalcemia or lithiasis during and after vitamin D supplementation.
- Immunologic follow-up of T cells and B cells homeostasis (including Treg and Th17) and gene expression profile in PBMCs using TRANSCRIPTOMIC analysis, before, during and after vitamin D supplementation.
- Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI) during and after vitamin D supplementation.
Schedule : Duration of patients' inclusion period is estimated 3
- Conditions
- Vitamin D Deficiency
- Being tested
- cholecalciferol
- Keywords
- Systemic lupus erythematosus, vitamin D supplementation, regulatory T cells, Th17 cells
- Medical subject headings
- Vitamin D Deficiency, 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 100 000 UI of cholecalciferol per week during 4, then 100 000 UI of cholecalciferol per month for 6 months
100 000 UI of cholecalciferol per week during 4 then 100 000 UI of cholecalciferol per month for 6 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunologic follow-up of T cells and B cells homeostasis (including regulatory T cells and Th17 cells) and gene expression profile of PBMCs using TRANSCRIPTOMIC analysis, before, during and after vitamin D supplementation
Immunologic follow-up of T cells and B cells homeostasis (including regulatory T cells and Th17 cells) and gene expression profile of PBMCs using TRANSCRIPTOMIC analysis, before, during and after vitamin D supplementation
Measured: 6 months
Secondary outcomes (2)
Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation
Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation
Measured: 6 months
Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)
Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- 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 Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Costedoat-Chalumeau, PUPH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413230
- Sponsor's protocol ID
- Record AP
- Acronym
- VITALUP
- Status last verified
- Jun 2011
- First submitted
- 24 Jun 2011
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01413230
- Acronym / sponsor ID
- VITALUP / Record AP
- Conditions
- Vitamin D Deficiency
- Keywords
- Systemic lupus erythematosus, vitamin D supplementation, regulatory T cells, Th17 cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Aug 2011 (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.
Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the skin, the joints, the nervous system and the kidney and may be life threatening.
SLE is associated with production of autoantibodies and perturbations in regulatory T cells and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).
Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.
Immunomodulatory effects of vitamin D supplementation in VITRO was recently described, notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and CD8+ T cells and the decrease of Th17 cells.
Detailed description
Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the skin, the joints, the nervous system and the kidney and may be life threatening.
SLE is associated with production of autoantibodies and perturbations in regulatory T cells and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).
Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.
Immunomodulatory effects of vitamin D supplementation in VITRO was recently described, notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and CD8+ T cells and the decrease of Th17 cells.
Objective : To evaluate the cellular immune response after vitamin D supplementation in patients with SLE.
Methods : This is an open prospective trial. SLE patients with hypovitaminosis D (< 30 ng/mL) receive vitamin D supplementation. 100 000 UI of cholecalciferol per week for 4 weeks then 100 000 UI of cholecalciferol per month for 6 months will be administered. All patients are followed after the beginning of vitamin D supplementation at month 2 and month 6.
End points :
- Clinical and biological tolerance: Absence of hypercalcemia or lithiasis during and after vitamin D supplementation.
- Immunologic follow-up of T cells and B cells homeostasis (including Treg and Th17) and gene expression profile in PBMCs using TRANSCRIPTOMIC analysis, before, during and after vitamin D supplementation.
- Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI) during and after vitamin D supplementation.
Schedule : Duration of patients' inclusion period is estimated 3
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with SLE
Key inclusion criteria (4 listed)
- Systemic lupus erythematosus
- Age > 18 years
- Serum vitamin D levels [25(OH)D] < 30 ng/mL
- Low to moderate active disease without modification of associated treatments
Key exclusion criteria (3 listed)
- Pregnancy
- Serum 25(OH)D levels > 30 ng/mL
- Flare requiring modification of treatments
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: 100 000 UI of cholecalciferol per week during 4, then 100 000 UI of cholecalciferol per month for 6 months100 000 UI of cholecalciferol per week during 4 then 100 000 UI of cholecalciferol per month for 6 months | Drug | – |
Primary outcome
Immunologic follow-up of T cells and B cells homeostasis (including regulatory T cells and Th17 cells) and gene expression profile of PBMCs using TRANSCRIPTOMIC analysis, before, during and after vitamin D supplementation
Time frame: 6 months
Immunologic follow-up of T cells and B cells homeostasis (including regulatory T cells and Th17 cells) and gene expression profile of PBMCs using TRANSCRIPTOMIC analysis, before, during and after vitamin D supplementation
2 secondary outcomes
Clinical tolerance: Absence of Hypercalcemia and lithiasis during and after vitamin D supplementation
Time frame: 6 months
Clinical efficacy: follow-up of clinical manifestations of SLE and disease activity score (SLEDAI)
Time frame: 6 months
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 24 Nov 2011.
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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.
Nathalie Costedoat-Chalumeau, PUPH principal investigator
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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 4 inclusion and 3 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 24 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
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?
Immunologic follow-up of T cells and B cells homeostasis (including regulatory T cells and Th17 cells) and gene expression profile of PBMCs using TRANSCRIPTOMIC analysis, before, during and after vitamin D supplementation (time frame: 6 months). 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 24 Nov 2011.