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Trial registered on ANZCTR


Registration number
ACTRN12612000560897
Ethics application status
Approved
Date submitted
28/03/2012
Date registered
25/05/2012
Date last updated
24/01/2013
Type of registration
Retrospectively registered

Titles & IDs
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.
Secondary ID [1] 280103 0
Nill
Universal Trial Number (UTN)
The Universal Trial Number (UTN) is U1111-1131-2210
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sickle cell disease 286016 0
Vitamin D status 286017 0
Condition category
Condition code
Blood 286204 286204 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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, and normal BMD according to WHO criteria: intervention was introduced with oral vitamin D supplements (Cholecalciferol tablet 50.000 IU/week for 3 months) and should come back after three months to check their VD serum levels. However, patients with optimal VD serum levels (>50 nmol/l), irrespective of their BMD, were not given any therapy.
For recording pain scores, crisis or utilization of care a daily dairy for a whole month was designed with four different colors indicating; no pain, mild, moderate and severe pain. Four dairies were provided for each patient, one should be filled before therapy start and the rests during the therapy. Further evaluation of vitamin D status and chronic musculoskeletal pain in SCD patients is being evaluated
Intervention code [1] 284429 0
Treatment: Drugs
Comparator / control treatment
Group C (Arm 3) is deemed to be the active control group. Group C outcome will be compared with group A and group B outcomes (both dose and route comparison).
Control group
Active

Outcomes
Primary outcome [1] 286834 0
serum levels of vitamin D
Timepoint [1] 286834 0
at baseline and at 4, 8 and 12 weeks after intervention commencement (i.e. pre-dose)
Primary outcome [2] 286835 0
Bone mineral density (BMD) as assessed by DEXA (Dual Energy X-ray Absorbtiometry).
Timepoint [2] 286835 0
at baseline and at and at the end of the study (12 weeks after intervention commencement)
Primary outcome [3] 286836 0
Chronic pain as assessed by Visual Analogue Scale (VAS).
Timepoint [3] 286836 0
at baseline and at 4, 8 and 12 weeks after intervention commencement
Secondary outcome [1] 296779 0
inflammatory condition as assessed by measuring serum levels of inflammatory cytokines (IL-6 and TNF-alfa).
Timepoint [1] 296779 0
at baseline and at and at the end of the study (12 weeks after intervention commencement).
Secondary outcome [2] 296780 0
inflammatory condition as assessed by measuring serum levels of C-reactive proteins (CRP).
Timepoint [2] 296780 0
at baseline and at and at the end of the study (12 weeks after intervention commencement).
Secondary outcome [3] 296781 0
Serum levels of para-thyroid hormone (PTH)
Timepoint [3] 296781 0
at baseline and at and at the end of the study (12 weeks after intervention commencement).
Secondary outcome [4] 296782 0
Serum levels calcium
Timepoint [4] 296782 0
at baseline and at 4, 8 and 12 weeks after intervention commencement (i.e. pre-dose)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
30/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 4189 0
Bahrain
State/province [1] 4189 0
Manama

Funding & Sponsors
Funding source category [1] 284990 0
University
Name [1] 284990 0
Arabian Gulf University (AGU)
Country [1] 284990 0
Bahrain
Primary sponsor type
Individual
Name
Dr Adla Bakri Hassan
Address
Arabian Gulf University (AGU)
Internal Medicine department
P.O. Box 26671
Manama, kingdom of Bahrain
Country
Bahrain
Secondary sponsor category [1] 283856 0
None
Name [1] 283856 0
Address [1] 283856 0
Country [1] 283856 0
Other collaborator category [1] 260667 0
Hospital
Name [1] 260667 0
Salmaniya Medical Centre (SMC)
Address [1] 260667 0
Salmaniya Medical Centre (SMC)
Manama, kingdom of Bahrain
Country [1] 260667 0
Bahrain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286999 0
Research and Ethics committee at CMMS (collage of medicine and medical science)
Ethics committee address [1] 286999 0
Arabian Gulf Universuity (AGU)
P.O. Pox 26671
Manama, Bahrain
Ethics committee country [1] 286999 0
Bahrain
Date submitted for ethics approval [1] 286999 0
Approval date [1] 286999 0
13/02/2012
Ethics approval number [1] 286999 0
95
Ethics committee name [2] 287098 0
The Research Committee at Salmaniya Medical Complex
Ethics committee address [2] 287098 0
Salmanyia Medical Complex (SMC)
Building 255, road 3904, block 329
Manama, Bahrain.
Ethics committee country [2] 287098 0
Bahrain
Date submitted for ethics approval [2] 287098 0
Approval date [2] 287098 0
27/03/2012
Ethics approval number [2] 287098 0

Summary
Brief summary
About 70 adult SCD subjects (equal to or greater than 18 years old) who are followed at hematology outpatient clinic at SMC were enrolled into this study. We will assess baseline characteristics including VD serum levels, pro-inflammatory markers such as cytokine serum levels (TNT-alfa and IL-6), and CRP, baseline hemoglobin and other laboratory parameters (Ca++, phosphate, alkaline phosphatase, and PTH) have been done. Furthermore, BMD has been determined using DEXA. All investigated parameters will be correlated with the self-reported overall pain score recorded daily in a diary using visual analog scale (VAS), as well as with frequency of hospital and home opiate use, frequency of hospitalization and blood transfusion. During the first visit an informed consent form was filled by each single patient and a copy was given to the patient.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33887 0
Dr Dr Adla Bakri Hassan
Address 33887 0
Arabian Gulf University (AGU) Collage of Medicine and Medical science (CMMS) Internal Medicine department P.O. Box 26671 Manama, Bahrain
Country 33887 0
Bahrain
Phone 33887 0
+973, 39764145
Fax 33887 0
+973, 17231090
Email 33887 0
[email protected]
Contact person for public queries
Name 17134 0
Dr Adla Bakri Hassan
Address 17134 0
Arabian Gulf University (AGU)
Collage of Medicine and Medical science (CMMS)
Internal Medicine department
P.O. Box 26671
Manama, Bahrain
Country 17134 0
Bahrain
Phone 17134 0
+973, 39764145
Fax 17134 0
+973, 17231090
Email 17134 0
[email protected]
Contact person for scientific queries
Name 8062 0
Dr Adla Bakri Hassan
Address 8062 0
Arabian Gulf University (AGU)
Collage of Medicine and Medical science (CMMS)
Internal Medicine department
P.O. Box 26671
Manama, Bahrain
Country 8062 0
Bahrain
Phone 8062 0
+973, 39764145
Fax 8062 0
+973, 39764145
Email 8062 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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