Systemic Lupus ErythematosusPhase 2NCT01709474
Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus
A Phase 2 study testing Vitamin D3 6000 IU and Vitamin D3 400 IU in people with Systemic Lupus Erythematosus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.
Trial summary
The primary objective of this study is to evaluate the effects of 18 weeks of high-dose vitamin D3 supplementation compared with standard-dose vitamin D3 supplementation on immune function, glucose homeostasis, and bone metabolism in children with systemic lupus erythematosus (SLE) and serum 25-hydroxyvitamin D… Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Vitamin D3 6000 IU and Vitamin D3 400 IU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 13 sitesUnited States
- Study dates
- Jun 2013to Jul 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written informed consent signed by the subject or parent/guardian as appropriate; child assent as appropriate;
- Before the age of 19, met at least 4 of the 11 modified American College of Rheumatology (ACR) 1982 Revised Criteria for the Classification of Systemic Lupus Erythematosus as updated in 1997;
- Date of SLE diagnosis (as described in Inclusion Criterion 2) at least 24 weeks prior to randomization;
- Serum 25-hydroxyvitamin D [25(OH)D] < 20 ng/mL at Screening;
- SELENA SLEDAI score > 0 and < 8 at Screening and at Baseline;
- If taking prednisone (or equivalent corticosteroid), the dose must be ≤ 15 mg/day or ≤0.5 mg/kg/day, whichever is lower, and stable for at least four weeks prior to randomization. Note, if subjects are taking steroids every other day, divide their dose by 2 to evaluate eligibility;
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- Stable immunosuppressive dose for at least 12 weeks prior to randomization;
- --Immunosuppressive medications allowed include mycophenolate (MMF), azathioprine, methotrexate, antimalarial medications (e.g., hydroxychloroquine), cyclosporine A (CsA), tacrolimus, intravenous immune globulin (IVIG), and abatacept.
- Body weight > 25 kg;
- Able to swallow pills;
- Males and females with reproductive potential must agree to practice effective measures of birth control.
Who cannot join
- Any condition or treatment that, in the opinion of the investigator, places the subject at an unacceptable risk as a participant in the trial;
- Current pharmacologic vitamin D2 or D3 intake > 800 IU daily or use of calcitriol at any dose over the past four weeks prior to randomization;
- Cyclophosphamide or IV glucocorticoid exposure within 12 weeks prior to randomization;
- Any BILAG A or B manifestation with the exception of a BILAG B mucocutaneous manifestation at screening, and excluding the renal BILAG criteria (see rituximab or belimumab criterion, below);
- Significant renal insufficiency defined as:
- Estimated GFR < 60 mL/min/1.73m^2 or estimated GFR < 90 mL/min/1.73m^2 with a reduction of the GFR by > 15% from the last measurement;
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- Urine dipstick value of 2+ or higher for protein, unless this is a stable value from the last measurement or, urine protein-creatinine ratio ≥ 50 mg/mmol unless the value represents an improvement of ≥ 25% from the last measurement.
- Rituximab or belimumab exposure use within 24 weeks prior to randomization;
- The following laboratory parameters at the Screening visit:
- Platelets < 50,000; WBC < 2,500; ANC < 1,000;
- Hemoglobin < 9 mg/dL;
- ALT, AST, bilirubin > 2x upper limit of normal (ULN);
- Hypercalcemia (calcium > ULN);
- Hypercalciuria (urinary calcium/creatinine ratio > 0.2).
- Primary hyperparathyroidism (known);
- History of nephrolithiasis (known);
- Diabetes mellitus requiring insulin therapy;
- Medications that interfere with vitamin D absorption;
- History of vertebral compression fractures (known);
- Pregnancy (girls ≥ 11 years of age must have a negative urine/serum pregnancy test);
- A history of non-adherence/non-compliance;
- Other investigational drug and/or treatment during the four weeks or seven half-lives of the other investigational drug prior to the start of study product dosing (Day 0), whichever is the greater length of time to enrollment;
- Current diagnosis of cancer or chronic infection such as Hepatitis B, Hepatitis C, or tuberculosis;
- Treatment with digoxin;
- Flu (influenza) vaccination within one week prior to randomization.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Children's Medical Center of Dallas
Dallas, Texas, 75235
Duke University Medical Center
Durham, North Carolina, 27710
Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Hospital Los Angeles
Los Angeles, California, 90027
Columbia University
New York, New York, 10032
Lucile Packard Children's Hospital, Stanford University
Palo Alto, California, 94304
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Rochester
Rochester, New York, 14642
UCSF School of Medicine
San Francisco, California, 94143
Seattle Children's Hospital
Seattle, Washington, 98101
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Vitamin D3 Effects on Immune Function in Pediatric Systemic Lupus Erythematosus (SLE)
The primary objective of this study is to evaluate the effects of 18 weeks of high-dose vitamin D3 supplementation compared with standard-dose vitamin D3 supplementation on immune function, glucose homeostasis, and bone metabolism in children with systemic lupus erythematosus (SLE) and serum 25-hydroxyvitamin D [25(OH)D] levels ≤20 ng/mL.
Read the detailed description
This is a multi-center, phase II, 18-week, two arm, unblinded randomized clinical trial.
Seventy-eight pediatric subjects with SLE and 25(OH)D levels ≤ 20 ng/mL will be randomized in a 1:1 ratio to receive either standard-dose (400 IU/day) or high-dose (6,000 IU/day) vitamin D3 for 18 weeks based upon weight at baseline. Subjects randomized to the high-dose vitamin D3 treatment arm will receive 6,000 IU per day from baseline until the subject's vitamin D levels reach ≥ 40 ng/mL at which point the vitamin D3 dose will be reduced to 4,000 IU per day. Subjects randomized to the high-dose treatment arm weighing < 40 kg will receive supplementation five days per week and all other subjects will receive supplementation seven days a week.
In addition to the baseline, and weeks 6, 12, and 18 visits, subjects randomized to the high-dose treatment arm will return at Weeks 3 and 9 to assess for symptoms of vitamin D toxicity. If a subject in the high-dose arm is found to exhibit evidence of vitamin D toxicity at the week 12 visit, he/she will be asked to return to their clinical research site for an additional vitamin D toxicity assessment at week 15. Study personnel will record each subject's interval history, assess adverse events, disease activity, and collect samples for safety and mechanistic assessments.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Vitamin D3 6000 IU, Vitamin D3 400 IU
- Keywords
- SLE, Vitamin D3, Vitamin D deficiency, IFN alpha expression
- Medical subject headings
- Lupus Erythematosus, Systemic, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 6000 IUDrug
Also called high-dose vitamin D, high-dose cholecalciferol (D3), high-dose 25(OH)D
Subjects will receive 6,000 IU of vitamin D3 by mouth daily until the subject's serum 25(OH) level is ≥ 40ng/mL at which point the supplementation dose will be reduced to 4,000 IU/day. Note: Subjects weighing <40 kilograms (kg) at study entry will receive their dose five days a week and all other subjects seven days a week.
Vitamin D3 400 IUDrug
Also called standard-dose vitamin D, standard-dose cholecalciferol (D3), standard-dose 25(OH)D
Subjects will receive 400 IU/day of vitamin D3 daily by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 6000 IU | Experimental | 6000 IU of vitamin D3 by mouth daily until the subject's serum 25(OH) level is ≥ 40ng/mL at which point the supplementation dose is reduced to 4,000 IU/day. Note: Subjects weighing <40 kilograms (kg) at study entry will receive their dose five days a week and all other subjects seven days a week. Receives: Drug: Vitamin D3 6000 IU |
| Vitamin D3 400 IU | Active comparator | 400 IU/day of vitamin D3 by mouth daily. Receives: Drug: Vitamin D3 400 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average IFN Module Expression Level
No mechanistic analyses were performed due to recruitment feasibility issues.
Measured: Baseline to Week 18
Percentage of Subjects by Treatment Arm Experiencing Any Adverse Event (AE) ≥ Grade 3
Adverse event grading based on National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0
Measured: Baseline to 18 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startJun 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Autoimmunity Centers of Excellence
- Responsible party
- Sponsor
- Investigators
- Jon M Burnham, MD, MSCE, Study chair, University of PennsylvaniaEmily Von Scheven, MD, MAS, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709474
- Sponsor's protocol ID
- DAIT ALE05
- Status last verified
- Dec 2015
- First submitted
- 16 Oct 2012
- Last updated
- 17 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D3 Effects on Immune Function in Pediatric Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT01709474
- Acronym / sponsor ID
- DAIT ALE05
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, Vitamin D3, Vitamin D deficiency, IFN alpha expression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Autoimmunity Centers of Excellence
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Posted 3 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the effects of 18 weeks of high-dose vitamin D3 supplementation compared with standard-dose vitamin D3 supplementation on immune function, glucose homeostasis, and bone metabolism in children with systemic lupus erythematosus (SLE) and serum 25-hydroxyvitamin D [25(OH)D] levels ≤20 ng/mL.
Detailed description
This is a multi-center, phase II, 18-week, two arm, unblinded randomized clinical trial.
Seventy-eight pediatric subjects with SLE and 25(OH)D levels ≤ 20 ng/mL will be randomized in a 1:1 ratio to receive either standard-dose (400 IU/day) or high-dose (6,000 IU/day) vitamin D3 for 18 weeks based upon weight at baseline. Subjects randomized to the high-dose vitamin D3 treatment arm will receive 6,000 IU per day from baseline until the subject's vitamin D levels reach ≥ 40 ng/mL at which point the vitamin D3 dose will be reduced to 4,000 IU per day. Subjects randomized to the high-dose treatment arm weighing < 40 kg will receive supplementation five days per week and all other subjects will receive supplementation seven days a week.
In addition to the baseline, and weeks 6, 12, and 18 visits, subjects randomized to the high-dose treatment arm will return at Weeks 3 and 9 to assess for symptoms of vitamin D toxicity. If a subject in the high-dose arm is found to exhibit evidence of vitamin D toxicity at the week 12 visit, he/she will be asked to return to their clinical research site for an additional vitamin D toxicity assessment at week 15. Study personnel will record each subject's interval history, assess adverse events, disease activity, and collect samples for safety and mechanistic assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 6000 IU | Experimental | Drug: Vitamin D3 6000 IU6000 IU of vitamin D3 by mouth daily until the subject's serum 25(OH) level is ≥ 40ng/mL at which point the supplementation dose is reduced to 4,000 IU/day. Note: Subjects weighing <40 kilograms (kg) at study entry will receive their dose five days a week and all other subjects seven days a week. |
| Vitamin D3 400 IU | Active comparator | Drug: Vitamin D3 400 IU400 IU/day of vitamin D3 by mouth daily. |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Written informed consent signed by the subject or parent/guardian as appropriate; child assent as appropriate;
- Before the age of 19, met at least 4 of the 11 modified American College of Rheumatology (ACR) 1982 Revised Criteria for the Classification of Systemic Lupus Erythematosus as updated in 1997;
- Date of SLE diagnosis (as described in Inclusion Criterion 2) at least 24 weeks prior to randomization;
- Serum 25-hydroxyvitamin D [25(OH)D] < 20 ng/mL at Screening;
- SELENA SLEDAI score > 0 and < 8 at Screening and at Baseline;
Key exclusion criteria (25 listed)
- Any condition or treatment that, in the opinion of the investigator, places the subject at an unacceptable risk as a participant in the trial;
- Current pharmacologic vitamin D2 or D3 intake > 800 IU daily or use of calcitriol at any dose over the past four weeks prior to randomization;
- Cyclophosphamide or IV glucocorticoid exposure within 12 weeks prior to randomization;
- Any BILAG A or B manifestation with the exception of a BILAG B mucocutaneous manifestation at screening, and excluding the renal BILAG criteria (see rituximab or belimumab criterion, below);
- Significant renal insufficiency defined as:
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 |
|---|---|---|
| Vitamin D3 6000 IUAlso: high-dose vitamin D, high-dose cholecalciferol (D3), high-dose 25(OH)DSubjects will receive 6,000 IU of vitamin D3 by mouth daily until the subject's serum 25(OH) level is ≥ 40ng/mL at which point the supplementation dose will be reduced to 4,000 IU/day. Note: Subjects weighing <40 kilograms (kg) at study entry will receive their dose five days a week and all other subjects seven days a week. | Drug | Vitamin D3 6000 IU |
| Vitamin D3 400 IUAlso: standard-dose vitamin D, standard-dose cholecalciferol (D3), standard-dose 25(OH)DSubjects will receive 400 IU/day of vitamin D3 daily by mouth. | Drug | Vitamin D3 400 IU |
Primary outcome
Change in Average IFN Module Expression Level
Time frame: Baseline to Week 18
No mechanistic analyses were performed due to recruitment feasibility issues.
Percentage of Subjects by Treatment Arm Experiencing Any Adverse Event (AE) ≥ Grade 3
Time frame: Baseline to 18 Weeks
Adverse event grading based on National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
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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.
Jon M Burnham, MD, MSCE study chair
University of Pennsylvania
Emily Von Scheven, MD, MAS study chair
University of California, San Francisco
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 6000 IU and Vitamin D3 400 IU in people with Systemic Lupus Erythematosus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites 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 11 inclusion and 25 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: stopped early, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Average IFN Module Expression Level (time frame: Baseline to Week 18). The study lists 2 primary outcomes in all. 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 17 Dec 2015.