Clinical Trial: Vitamin D Status, Disease Specific and Quality of Life Outcomes in Patients With Cutaneous Lupus

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Vitamin D Status, Disease Specific and Quality of Life Outcomes in Patients With Cutaneous Lupus

Brief 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. 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

Detailed Summary:
Sponsor: Emory University

Current Primary Outcome: cutaneous lupus severity as measured by the CLASI instrument(Cutaneous Lupus Erythematosus Disease Area and Severity Index) [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Quality of life as measured by the Skindex 29 [ Time Frame: 1 year ]
  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.
• serum 25-hydroxy vitamin D [ Time Frame: 1 year ]
  a blood test to asses 25-hydroxy vitamin D level

Original Secondary Outcome:

• Quality of life as measured by the Skindex 29 [ Time Frame: 1 year ]
  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. We propose to use the Skindex-29, with three independent scores that can be used in the measurement of health related QOL in dermatological patients.
• serum 25-hydroxy vitamin D [ Time Frame: 1 year ]
  a blood test to asses 25-hydroxy vitamin D level

Dates:
Date Received: December 21, 2011
Date Started: December 2011
Date Completion:
Last Updated: November 18, 2013
Last Verified: June 2013