Systemic Lupus ErythematosusNCT01892748
Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.
A study testing Cholecalciferol in people with Systemic Lupus Erythematosus, run by ROSA MARIA RODRIGUES PEREIRA at 1 site in Brazil.
Trial summary
The potential role of vitamin D on disease susceptibility, activity and severity has been considered for several autoimmune rheumatologic diseases include systemic lupus erythematosus (SLE) . Read more about this study
- Who is it for?
- Ages 10 to 25 years, women only
- 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?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to Feb 2014
- Phase
- Interventional
- 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 10 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written informed consent signed
- 4 of the 11 modified American College of Rheumatology (ACR) Revised Criteria for the Classification of Systemic Lupus Erythematosus .
- SLEDAI < 8 at Screening and at Baseline
- Stable immunosuppressive dose prior to randomization.
- Body Mass Index < 30
- Able to swallow pills at randomization
Who cannot join
- Refuse of the patient or the legal responsible
- Use of vitamin D2 or D3 supplementation
- Significant renal insufficiency
- Primary hyperparathyroidism (known)
- History of nephrolithiasis (known)
- Diabetes mellitus requiring insulin therapy
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- History of vertebral compression fractures (known)
- Pregnancy
- Use of bisphosphonates
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo - School of Medicine
São Paulo, São Paulo, 01246-903
About this study
Official title: Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus.
The potential role of vitamin D on disease susceptibility, activity and severity has been considered for several autoimmune rheumatologic diseases include systemic lupus erythematosus (SLE) . Although, there are few studies of vitamin D supplementation in SLE patients, especially in Juvenile Onset Systemic Lupus Erythematosus (JoSLE).
The objective of this study is to evaluate the effect of vitamin D supplementation (cholecalciferol 50.000 international units (IU)/week for 24 weeks) on disease activity (clinical and laboratory parameters), fatigue and bone mass.
Read the detailed description
This is a study 24-week, two arm, double blinded randomized clinical trial to evaluate the effects of high-dose vitamin D3 supplementation compared with placebo, on activity disease, fatigue and bone mass.
Sixty JoSLE patients will be randomized to receive placebo or vitamin D3 (50.000 IU/week) for 24weeks. The patients return to visits in week 12 and week 24 for evaluation. Study will record clinical history, drugs in use, disease activity, and bone mass parameters.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Cholecalciferol, Placebo
- Keywords
- Lupus, Juvenile, Cholecalciferol, Disease activity, Bone Mass, Fatigue, Safety
- Medical subject headings
- Lupus Erythematosus, Systemic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Vitamin D3
All patients and physicians were blinded to group assignment and treatment allocation. The first group received oral cholecalciferol of 50,000 IU/week and for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters.
PlaceboDrug
Also called No other names
The second group received identical placebo tablets for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters.
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol 50.000IU/week | Active comparator | patients will receive vitamin D3 (50.000 IU/week) for 24weeks Receives: Drug: Cholecalciferol |
| Placebo | Placebo comparator | patients receive placebo in similar capsules of cholecalciferol for 24weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Disease Activity Score (SLEDAI)
Measured: baseline to week 12 and 24
Secondary outcomes (2)
The change in Fatigue Score
Measured: baseline to week 12 and 24
The change in Bone Mineral Parameters
Measured: baseline to week 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startJul 2012
- Primary completionAug 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ROSA MARIA RODRIGUES PEREIRA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ROSA MARIA RODRIGUES PEREIRA, University of Sao Paulo
- Investigators
- Rosa MR Pereira, MD PhD, Principal investigator, University of Sao Paulo - School of MedicineGlauce L Lima, MD, Study chair, University of Sao Paulo - School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892748
- Sponsor's protocol ID
- VITD59/11
- Status last verified
- May 2016
- First submitted
- 17 Jun 2013
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lima GL, Paupitz JA, Aikawa NE, Alvarenga JC, Pereira RMR. A randomized double-blind placebo-controlled trial of vitamin D supplementation in juvenile-onset systemic lupus erythematosus: positive effect on trabecular microarchitecture using HR-pQCT. Osteoporos Int. 2018 Mar;29(3):587-594. doi: 10.1007/s00198-017-4316-5. Epub 2017 Nov 19.
PubMed 29152675Lima GL, Paupitz J, Aikawa NE, Takayama L, Bonfa E, Pereira RM. Vitamin D Supplementation in Adolescents and Young Adults With Juvenile Systemic Lupus Erythematosus for Improvement in Disease Activity and Fatigue Scores: A Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Care Res (Hoboken). 2016 Jan;68(1):91-8. doi: 10.1002/acr.22621.
PubMed 25988278
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus.
- ClinicalTrials.gov ID
- NCT01892748
- Acronym / sponsor ID
- VITD59/11
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, Juvenile, Cholecalciferol, Disease activity, Bone Mass, Fatigue, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ROSA MARIA RODRIGUES PEREIRAUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 Jul 2013 (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 potential role of vitamin D on disease susceptibility, activity and severity has been considered for several autoimmune rheumatologic diseases include systemic lupus erythematosus (SLE) . Although, there are few studies of vitamin D supplementation in SLE patients, especially in Juvenile Onset Systemic Lupus Erythematosus (JoSLE).
The objective of this study is to evaluate the effect of vitamin D supplementation (cholecalciferol 50.000 international units (IU)/week for 24 weeks) on disease activity (clinical and laboratory parameters), fatigue and bone mass.
Detailed description
This is a study 24-week, two arm, double blinded randomized clinical trial to evaluate the effects of high-dose vitamin D3 supplementation compared with placebo, on activity disease, fatigue and bone mass.
Sixty JoSLE patients will be randomized to receive placebo or vitamin D3 (50.000 IU/week) for 24weeks. The patients return to visits in week 12 and week 24 for evaluation. Study will record clinical history, drugs in use, disease activity, and bone mass parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol 50.000IU/week | Active comparator | Drug: Cholecalciferolpatients will receive vitamin D3 (50.000 IU/week) for 24weeks |
| Placebo | Placebo comparator | Drug: Placebopatients receive placebo in similar capsules of cholecalciferol for 24weeks |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Written informed consent signed
- 4 of the 11 modified American College of Rheumatology (ACR) Revised Criteria for the Classification of Systemic Lupus Erythematosus .
- SLEDAI < 8 at Screening and at Baseline
- Stable immunosuppressive dose prior to randomization.
- Body Mass Index < 30
Key exclusion criteria (9 listed)
- Refuse of the patient or the legal responsible
- Use of vitamin D2 or D3 supplementation
- Significant renal insufficiency
- Primary hyperparathyroidism (known)
- History of nephrolithiasis (known)
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 D3All patients and physicians were blinded to group assignment and treatment allocation. The first group received oral cholecalciferol of 50,000 IU/week and for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters. | Drug | Cholecalciferol 50.000IU/week |
| PlaceboAlso: No other namesThe second group received identical placebo tablets for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters. | Drug | Placebo |
Primary outcome
The change in Disease Activity Score (SLEDAI)
Time frame: baseline to week 12 and 24
2 secondary outcomes
The change in Fatigue Score
Time frame: baseline to week 12 and 24
The change in Bone Mineral Parameters
Time frame: baseline to week 12 and 24
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 12 May 2016.
- Derived from this study: PubMed 29152675Lima GL, Paupitz JA, Aikawa NE, Alvarenga JC, Pereira RMR. A randomized double-blind placebo-controlled trial of vitamin D supplementation in juvenile-onset systemic lupus erythematosus: positive effect on trabecular microarchitecture using HR-pQCT. Osteoporos Int. 2018 Mar;29(3):587-594. doi: 10.1007/s00198-017-4316-5. Epub 2017 Nov 19.
- Derived from this study: PubMed 25988278Lima GL, Paupitz J, Aikawa NE, Takayama L, Bonfa E, Pereira RM. Vitamin D Supplementation in Adolescents and Young Adults With Juvenile Systemic Lupus Erythematosus for Improvement in Disease Activity and Fatigue Scores: A Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Care Res (Hoboken). 2016 Jan;68(1):91-8. doi: 10.1002/acr.22621.
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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.
Rosa MR Pereira, MD PhD principal investigator
University of Sao Paulo - School of Medicine
Glauce L Lima, MD study chair
University of Sao Paulo - School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Systemic Lupus Erythematosus, run by ROSA MARIA RODRIGUES PEREIRA at 1 site in Brazil.
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 6 inclusion and 9 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 12 May 2016. 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 Brazil. 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. 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.
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?
The change in Disease Activity Score (SLEDAI) (time frame: baseline to week 12 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01892748, which also lists 2 linked publications.
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 12 May 2016.