Vitamin D and immune responses in haematopoietic stem cell transplant
Research type
Research Study
Full title
Vitamin D and immune responses in haematopoietic stem cell transplantation
IRAS ID
225121
Contact name
Alejandro Madrigal
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Graft-versus-host disease (GvHD) is the most common complication and cause of non-relapse mortality (NRM) after allogeneic HSCT and donor lymphocyte infusion (DLI), affecting nearly half of the patients. Acute GvHD usually happens within the first 3 months after HSCT/DLI and the main organs impaired are skin, gut and liver. Vitamin D has proved to be involved in this process due to its important role in immunity. Steroids are used as immunosuppressive therapy (IS) for GvHD. However, less than 50% of patients respond to them, requiring stronger IS with a subsequent increase in side effects and mortality. Moreover, acute GvHD biomarkers have been found to have a key role in early diagnosis and prognosis but they have never been measured beyond one month post-transplant so their role in long-term follow-up and monitoring response to treatment has never been investigated. Furthermore, studies in chronic GvHD are scarce.
Studies in patients with asthma showed that patients with lower vitamin D are less responsive to steroids than dose with higher levels. This type of studies have never been performed in the HSCT setting hence the incidence of patients whose vitamin D levels are low hence would benefit from supplementation is unknown.
Patients who develop GvHD post HSCT / DLI and agree to participle in the study will be recruited and followed up for 6 months. A blood sample will be taken before starting on steroids (D0), 1, 3 and 6 months later to measure vitamin D and biomarkers of GvHD (ST2, elafin and REG3-alpha).The study will be carried out in 3 centres across the UK. Samples will be collected from each centre and shipped to Rotherham General Hospital at the end of the study to be processed, with a posterior data analysis.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0325
Date of REC Opinion
21 Aug 2017
REC opinion
Favourable Opinion