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

Vitamin D status and vitamin D therapy in adult Bahraini sickle cell patients with chronic pain.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000560897
Enrollment
70
Registered
2012-05-25
Start date
2012-04-01
Completion date
2012-06-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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

Sponsors

Dr Adla Bakri Hassan
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026