Vitamin D therapy in patients with sickle cell disease (SCD)

Not Applicable

Active, not recruiting

Conditions: Vitamin D status
Blood - Haematological diseases
sickle cell disease

Registration Number: ACTRN12612000560897

Lead Sponsor: Dr Adla Bakri Hassan

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

Inclusion Criteria:
1. Patients with positive genotypes for sickle cell disease (HbSS).
2. Bahraini patients.
3. Adults male or female patients, age equal to or greater than 18 years old.
4. Last blood transfusion equal to or greater than 30 days prior.
5. Patients on hydroxyurea (HU), if it cannot be withheld.

Exclusion Criteria

Exclusion Criteria:
1. Any chronic co-morbidity (e.g. renal, liver diseases, or hypercalcaemia).
2. Recent hospitalization less than 14 days.
3. Recent blood transfusion (less than 30 days).
4. Patients currently on high dose VD therapy or other drugs which can interact with VD.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
serum levels of vitamin D[at baseline and at 4, 8 and 12 weeks after intervention commencement (i.e. pre-dose)];Bone mineral density (BMD) as assessed by DEXA (Dual Energy X-ray Absorbtiometry).[at baseline and at and at the end of the study (12 weeks after intervention commencement)];Chronic pain as assessed by Visual Analogue Scale (VAS).[at baseline and at 4, 8 and 12 weeks after intervention commencement]

Secondary Outcome Measures

Name	Time	Method
inflammatory condition as assessed by measuring serum levels of inflammatory cytokines (IL-6 and TNF-alfa).[at baseline and at and at the end of the study (12 weeks after intervention commencement).];inflammatory condition as assessed by measuring serum levels of C-reactive proteins (CRP).[at baseline and at and at the end of the study (12 weeks after intervention commencement).];Serum levels of para-thyroid hormone (PTH)[at baseline and at and at the end of the study (12 weeks after intervention commencement).];Serum levels calcium[at baseline and at 4, 8 and 12 weeks after intervention commencement (i.e. pre-dose)]