High Dose Vitamin D for Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Vitamin D; Placebo
Intervention description: 10,000 IU/caplet, patients receiving 240,000 IU to 600,000 IU cumulative Vitamin D dose based on weight.; placebo with daily calcium/Vitamin D soft chews
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized placebo controlled double blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 7 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: sickle cell disease; vitamin D; pediatrics; pain

Summary:

      Vitamin D deficiency (VDD) is very common among African American adolescents and adults in
      the US, ten times higher than is seen in Caucasians. VDD is also quite common in sickle cell
      disease (SCD). Both VDD and SCD can cause chronic pain, compression fractures, and muscle
      weakness. The investigators believe VDD may contribute to poor musculoskeletal health and
      chronic pain seen in pediatric SCD. In this study, the investigators aim to show that
      children and adolescents with SCD and chronic pain have lower levels of vitamin D compared to
      those without chronic pain. The investigators also aim to determine the clinical
      characteristics in SCD patients related to their vitamin D status.

      About 60 subjects (7 to 21 years old) will be enrolled on this study, 30 with chronic pain
      and 30 without chronic pain. The investigators will assess baseline characteristics including
      vitamin D levels, bone turnover rates (measured by C telopeptide blood levels [CTx]), markers
      of inflammation and oxidative stress levels in blood, baseline hemoglobin and other
      laboratory parameters, presence of abnormal bones on chest x-ray, pulmonary function, opioid
      analgesic use, overall muscle strength, quality of life and depression.

      To evaluate the impact of vitamin D replacement on these baseline characteristics, the
      investigators will randomize subjects to receive either placebo or high dose vitamin D for 6
      weeks after which time the investigators will evaluate overall vitamin D status, muscle and
      bone health, depression, quality of life, pain status and use of opioid pain medications,
      inflammation and oxidative status comparing before and after treatment with high dose vitamin
      D. The investigators will give-at no cost to subjects-a daily supplement that will provide
      the recommended daily allowance of calcium and vitamin D that contains 500mg Calcium and
      200IU vitamin D to subjects throughout the study period. Subjects will be in the study for 7
      months and have five to six study visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all sickle cell genotypes including SS, SB0thal, SC, SB+Thal

          -  Age 7-21 years old

          -  Last PRBC transfusion >30 days prior

        Exclusion Criteria:

          -  chronic renal failure

          -  chronic liver disease

          -  recent hospitalization <14 days

          -  history of malignancy

          -  serum calcium level as defined in protocol section D 2.2

          -  treatment with concommitant medications as defined in section D 2.2 of the protocol

          -  known malabsorption or short gut syndrome or conditions associated with poor GI
             absorption

          -  patients currently on high dose vitamin D therapy