Cutaneous Lupus ErythematosusPhase 2NCT01498406
Vitamin D Status, Disease Specific and Quality of Life Outcomes in Patients With Cutaneous Lupus
A Phase 2 study testing vitamin D in people with Cutaneous Lupus Erythematosus, run by Emory University at 1 site in United States.
Trial summary
Lupus is a disease in which the immune system, which normally fights infection, begins to attack healthy cells in the body. This phenomenon is called autoimmunity and what the immune system attacks is called the autoantigen. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Lupus Erythematosus
- What is being tested?
- vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jun 2013
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
- Inclusion Criteria for observational arm:
- Sites: Subjects will be primarily recruited from the Emory and Grady Memorial Hospital Dermatology Clinics. Additional recruitment will be from community dermatologists using a flyer since this is a relatively uncommon skin disease. This study will also be listed on the NIH and Lupus Foundation of America websites.
- Stage of Disease: A previous or new diagnosis of CLE, either clinically supported or confirmed by skin biopsy.
- Age: Adult subjects, greater than 18 years old. ii. Inclusion criteria for control group in observational arm: Dermatology patients with skin disease, but without CLE, with skin types IV, V, VI will be recruited for the control group. iii. Inclusion criteria for interventional arm: Patients with 25(OH)D levels <30ng/ml. iv. Exclusion Criteria:
- Patients who are already actively having their vitD levels monitored and repleted.
- Patients with 25(OH)D levels ≥30 ng/ml will be excluded from the RCT but are eligible for the observational arm of the study.
- Patients with systemic lupus as defined by the American Rheumatism Association criteria.
- Patients with renal lithiasis, hypercalcemia, inflammatory bowel disease, or sarcoidosis.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
About this study
Lupus is a disease in which the immune system, which normally fights infection, begins to attack healthy cells in the body. This phenomenon is called autoimmunity and what the immune system attacks is called the autoantigen. Lupus can affect many parts of the body and often affects the skin, with immune cells attacking autoantigens in the skin and causing a rash. This rash is often visible to the public because it tends to occur on sun-exposed areas, for example a patient's face, chest, and arms. For this reason, among others, skin lupus can be a source of disability and poor health related quality of life in many patients with this disease. It is not completely understood why or how someone might develop lupus, however there are likely many reasons which include their genetics and also the kind of environment they live in.
One such environmental factor, vitamin D, is more commonly known as a vitamin important for bone health. However, we are learning that vitamin D has effects all over the body, and is also important for a healthy immune system. Low levels of vitamin D have been associated with an increased risk of other autoimmune disorders such as diabetes and multiple sclerosis, and have also been found to be common in skin lupus patients.
Read more
Vitamin D is made in the skin when it is exposed to the sun, specifically ultraviolet B radiation (UVB). The main source of vitamin D for most people is its production in the skin because the normal American diet is not high in vitamin D. However, patients with skin lupus tend to stay out of the sun because their rash is made worse by sunlight, which is thought to produce more of the autoantigens in the skin attacked by the immune system. Additionally, as skin doctors (dermatologists) we recommend sun protection to skin lupus patients to minimize sun-sensitivity and prevent flares of their skin disease. However we may be putting them at risk for low vitamin D status and even more severe disease. Another risk factor that puts skin lupus patients at risk for vitamin D deficiency is that these patients generally have darker skin types which blocks UVB and further limits vitamin D production in the skin.
Given that skin lupus patients are at high risk for low vitamin D status as mentioned above, the investigators propose a research study that will provide information about vitamin D levels in these patients. The investigators seek to identify how many skin lupus patients have low vitamin D status and how vitamin D influences the natural history of this skin disease. Additionally the investigators will evaluate whether or not supplementation with high dose vitamin D will lessen the severity and negative quality of life impact of skin lupus. Supplementation of vitamin D by mouth is an inexpensive, well tolerated, and safe over the counter method to replete and maintain a normal vitamin D status. Studies in other autoimmune diseases, specifically Crohn's disease and multiple sclerosis, have shown that high dose vitamin D supplementation improves disease severity. It is the hope of the investigators that this will also be observed in skin lupus patients.
In summary, the investigators seek to move beyond establishing an association between vitamin D status and skin lupus. The investigators aim to elucidate the therapeutic benefit, if any, of vitamin D status on disease severity and quality of life while controlling for important factors that may influence vitamin D status. If the investigators are to show improvement in disease severity with vitamin D supplementation, this would be a cost-effective additional therapy to our standard clinical practice. Future research would also allow us to investigate other alternative markers of vitamin D deficiency and disease activity in skin lupus patients, a population at high risk for low vitamin D status and in need of further research.
- Conditions
- Cutaneous Lupus Erythematosus
- Being tested
- vitamin D
- Keywords
- cutaneous lupus erythematosus, vitamin D, quality of life
- Medical subject headings
- Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin DDietary supplement
Also called The investigators will be using vitamin D soft gels in 400 IU and 4,000 IU provided by Carlson laboratories.
The investigators will carry out a two-armed prospective pilot study of the influence of vitD on cutaneous lupus (CLE) disease severity. Patients with CLE will be eligible for an observational or interventional arm based on their 25(OH)D levels and consent. Subjects with low vitD status (<30 ng/mL) will be eligible for the investigational arm involving participation in a randomized controlled trial of daily high dose (4000 IU) vs. low dose (400 IU) vitD supplementation for 8 months. Subjects who have sufficient vitD status (>30ng/mL) or those with low vitD who choose not to participate in the RCT are eligible for continued participation in the observational arm of the study. All subjects will be followed at 4, 8, and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| high dose vitamin D3 | Experimental | 4,000 IU of vitamin D3 daily for 8 months Receives: Dietary Supplement: vitamin D |
| low dose vitamin D3 | Active comparator | 400 IU of vitamin D3 Receives: Dietary Supplement: vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
cutaneous lupus severity as measured by the CLASI instrument(Cutaneous Lupus Erythematosus Disease Area and Severity Index)
The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) is a validated CLE disease severity measure that has been in use in clinical trials since 2005. This scale captures cutaneous, mucosal membrane, and alopetic disease activity (erythema and scale/hypertrophy) as well as damage (dyspigmentation and scarring/ atrophy/ panniculitis).
Measured: 1 year
Secondary outcomes (2)
Quality of life as measured by the Skindex 29
No cutaneous lupus specific quality of life (QOL) measure exists, but the Skindex 29, a validated skin-specific QOL measure has been used in previous studies along with three added questions: two related to patient concerns about photosensitivity and one related to patient concerns about hair loss. The investigators propose to use the Skindex-29, with three independent scores that can be used in the measurement of health related QOL in dermatological patients.
Measured: 1 year
serum 25-hydroxy vitamin D
a blood test to asses 25-hydroxy vitamin D level
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: secondary to funding issues and low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Dermatology Foundation
- Responsible party
- Principal investigator, Laura K. DeLong, MD, MPH, Emory University
- Investigators
- Laura K DeLong, MD, MPH, Principal investigator, Emory Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498406
- Sponsor's protocol ID
- IRB00051622
- Status last verified
- Jun 2013
- First submitted
- 21 Dec 2011
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status, Disease Specific and Quality of Life Outcomes in Patients With Cutaneous Lupus
- ClinicalTrials.gov ID
- NCT01498406
- Acronym / sponsor ID
- IRB00051622
- Conditions
- Cutaneous Lupus Erythematosus
- Keywords
- cutaneous lupus erythematosus, vitamin D, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: secondary to funding issues and low enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Dermatology Foundation
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Dec 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.
Lupus is a disease in which the immune system, which normally fights infection, begins to attack healthy cells in the body. This phenomenon is called autoimmunity and what the immune system attacks is called the autoantigen. Lupus can affect many parts of the body and often affects the skin, with immune cells attacking autoantigens in the skin and causing a rash. This rash is often visible to the public because it tends to occur on sun-exposed areas, for example a patient's face, chest, and arms. For this reason, among others, skin lupus can be a source of disability and poor health related quality of life in many patients with this disease. It is not completely understood why or how someone might develop lupus, however there are likely many reasons which include their genetics and also the kind of environment they live in.
One such environmental factor, vitamin D, is more commonly known as a vitamin important for bone health. However, we are learning that vitamin D has effects all over the body, and is also important for a healthy immune system. Low levels of vitamin D have been associated with an increased risk of other autoimmune disorders such as diabetes and multiple sclerosis, and have also been found to be common in skin lupus patients.
Vitamin D is made in the skin when it is exposed to the sun, specifically ultraviolet B radiation (UVB). The main source of vitamin D for most people is its production in the skin because the normal American diet is not high in vitamin D. However, patients with skin lupus tend to stay out of the sun because their rash is made worse by sunlight, which is thought to produce more of the autoantigens in the skin attacked by the immune system. Additionally, as skin doctors (dermatologists) we recommend sun protection to skin lupus patients to minimize sun-sensitivity and prevent flares of their skin disease. However we may be putting them at risk for low vitamin D status and even more severe disease. Another risk factor that puts skin lupus patients at risk for vitamin D deficiency is that these patients generally have darker skin types which blocks UVB and further limits vitamin D production in the skin.
Given that skin lupus patients are at high risk for low vitamin D status as mentioned above, the investigators propose a research study that will provide information about vitamin D levels in these patients. The investigators seek to identify how many skin lupus patients have low vitamin D status and how vitamin D influences the natural history of this skin disease. Additionally the investigators will evaluate whether or not supplementation with high dose vitamin D will lessen the severity and negative quality of life impact of skin lupus. Supplementation of vitamin D by mouth is an inexpensive, well tolerated, and safe over the counter method to replete and maintain a normal vitamin D status. Studies in other autoimmune diseases, specifically Crohn's disease and multiple sclerosis, have shown that high dose vitamin D supplementation improves disease severity. It is the hope of the investigators that this will also be observed in skin lupus patients.
In summary, the investigators seek to move beyond establishing an association between vitamin D status and skin lupus. The investigators aim to elucidate the therapeutic benefit, if any, of vitamin D status on disease severity and quality of life while controlling for important factors that may influence vitamin D status. If the investigators are to show improvement in disease severity with vitamin D supplementation, this would be a cost-effective additional therapy to our standard clinical practice. Future research would also allow us to investigate other alternative markers of vitamin D deficiency and disease activity in skin lupus patients, a population at high risk for low vitamin D status and in need of further research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high dose vitamin D3 | Experimental | Dietary Supplement: vitamin D4,000 IU of vitamin D3 daily for 8 months |
| low dose vitamin D3 | Active comparator | Dietary Supplement: vitamin D400 IU of vitamin D3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 DAlso: The investigators will be using vitamin D soft gels in 400 IU and 4,000 IU provided by Carlson laboratories.The investigators will carry out a two-armed prospective pilot study of the influence of vitD on cutaneous lupus (CLE) disease severity. Patients with CLE will be eligible for an observational or interventional arm based on their 25(OH)D levels and consent. Subjects with low vitD status (<30 ng/mL) will be eligible for the investigational arm involving participation in a randomized controlled trial of daily high dose (4000 IU) vs. low dose (400 IU) vitD supplementation for 8 months. Subjects who have sufficient vitD status (>30ng/mL) or those with low vitD who choose not to participate in the RCT are eligible for continued participation in the observational arm of the study. All subjects will be followed at 4, 8, and 12 months. | Dietary supplement | high dose vitamin D3, low dose vitamin D3 |
Primary outcome
cutaneous lupus severity as measured by the CLASI instrument(Cutaneous Lupus Erythematosus Disease Area and Severity Index)
Time frame: 1 year
The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) is a validated CLE disease severity measure that has been in use in clinical trials since 2005. This scale captures cutaneous, mucosal membrane, and alopetic disease activity (erythema and scale/hypertrophy) as well as damage (dyspigmentation and scarring/ atrophy/ panniculitis).
2 secondary outcomes
Quality of life as measured by the Skindex 29
Time frame: 1 year
serum 25-hydroxy vitamin D
Time frame: 1 year
Results and safety
The study was stopped early (reason given: secondary to funding issues and low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
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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.
Laura K DeLong, MD, MPH principal investigator
Emory Dermatology
1 site 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 D in people with Cutaneous Lupus Erythematosus, run by Emory University 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?
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 20 Nov 2013. 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 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?
The study was stopped early (reason given: secondary to funding issues and low enrollment). Results are not available in the source record.
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?
cutaneous lupus severity as measured by the CLASI instrument(Cutaneous Lupus Erythematosus Disease Area and Severity Index) (time frame: 1 year). 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 20 Nov 2013.