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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12612000560897
• Date of registration: 25/05/2012
• Prospective Registration: No
• Primary sponsor: Dr Adla Bakri Hassan
• Public title: Vitamin D therapy in patients with sickle cell disease (SCD)
• Scientific title: Vitamin D status and vitamin D therapy in adult Bahraini sickle cell patients with chronic pain.
• Date of first enrolment: 01/04/2012
• Target sample size: 70
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12612000560897.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Bahrain

Contacts

• Name: Dr Dr Adla Bakri Hassan

• Name: Dr Dr Adla Bakri Hassan

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Blood - Haematological diseases

sickle cell disease;Vitamin D status;
sickle cell disease
Vitamin D status

Intervention(s)

Intervention with vitamin D therapy, which should be a maximum for three months, was introduced based on VD serum levels and BMD as described below. The patients were divided into three groups; A (Arm 1), B (Arm 2) and C (Arm 3). BMD measurement was done using Dual Energy X-ray Absorbtiometry (DEXA) at upper/neck femur, forearm and lumbar spine, osteopenia (T score between -1 to -2.5) and osteoporosis (A bone mineral density (BMD) greater than 2.5 standard deviations from the normal with T score less than or equal to -2.5) will be diagnosed as per the WHO criteria. BMD were requested for all patients as base line. BMD will be done twice, before the therapy as base line and later three months after the last dose of VD. Group A (Arm 1): Patients with VD deficiency (< 30nmol/l), and low BMD for osteoporosis or osteopenia according to WHO criteria: first dose therapeutic intervention was introduced with intramuscular vitamin D (IM VD), (Cholecalciferol (Arachitol-6L) 600,000 IU/month), but, the second dose will be decided after the second run of their serum VD levels one month later, if VD levels become normal no more therapy will be given and the patient will be out of the study, if the levels are still insufficient/deficient then a second IM injection dose will be given, again after one month the VD serum levels will be checked and a third dose will be decided accordingly. Group B (Arm 2): Patients with insufficient VD levels (30-50nmol/l), BMD score for osteoporosis/osteopenia according to WHO criteria: first dose therapeutic intervention was introduced with IM VD injection, Cholecalciferol 600,000 IU/month, unless the patient preferred tablets. For Group B the second and third doses will be decided as for Group A. Group C (Arm 3): Patients with insufficient VD levels, a

Primary Outcome(s)

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(s)

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 calcium[at baseline and at 4, 8 and 12 weeks after intervention commencement (i.e. pre-dose)]

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).]

Serum levels of para-thyroid hormone (PTH)[at baseline and at and at the end of the study (12 weeks after intervention commencement).]

Secondary ID(s)

Nill

Source(s) of Monetary Support

Arabian Gulf University (AGU)

Ethics review

Status: Approved
Approval date:
Contact:

Research and Ethics committee at CMMS (collage of medicine and medical science)

Status: Approved
Approval date:
Contact:

The Research Committee at Salmaniya Medical Complex