Effects of Vitamin D supplementation in HIV+ individuals on ART

• Research type

  Research Study

• Full title

  Effects of Vitamin D supplementation on Vitamin D levels and immune activation in HIV infected individuals on antiretroviral therapy

• IRAS ID

  62792

• Contact name

  Alastair Teague

• Sponsor organisation

  Guy's & St. Thomas' NHS Foundation Trust

• Eudract number

  2010-022775-57

• ISRCTN Number

  not given

• Research summary

  Vitamin D has several functions including improvement of immune function and muscle strength, reduction of inflammation, absorption of calcium from the diet and regulation of bone formation. The main sources of vitamin D are sunlight, diet and vitamin supplements. In previous studies of patients not infected with HIV, severe vitamin D deficiency has been associated with a higher risk of osteoporosis, muscle weakness, diabetes, and some cancers. Vitamin D is also necessary to activate T cells, a central component of the immune system, but the effect on HIV infection and its consequences is unknown. In HIV infected people, vitamin D deficiency is more common in the winter, in people of non-Caucasian ethnicity and in patients on HIV treatment. A study in Tanzania showed an association between low vitamin D levels and a higher risk of anaemia (low blood count), HIV disease progression and death. arge study has shown that treatment with efavirenz, a commonly used HIV drug, is associated with a significantly higher risk of vitamin D deficiency which is independent from season or ethnicity. Vitamin D supplementation in HIV infected patients has not previously been investigated and it is unknown whether increasing levels is associated with improved clinical outcome. We aim to investigate whether high dose vitamin D supplementation will increase vitamin D levels to within normal range and reduce the effects of HIV on the immune system.For this pilot study 40 HIV infected patients on HIV medication with vitamin D deficiency will be chosen at random to receive either high dose vitamin D or no extra treatment. They will then be followed up for 48 weeks and various aspects of vitamin D and immune functions will be measured including bone density. The results from this pilot study will inform a larger study to investigate this further.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  10/H0713/85

• Date of REC Opinion

  15 Apr 2011

• REC opinion

  Further Information Favourable Opinion