High Dose Vitamin D for Sickle Cell Disease

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.

Conditions

• Sickle Cell Disease

Interventions

DRUG

Vitamin D

10,000 IU/caplet, patients receiving 240,000 IU to 600,000 IU cumulative Vitamin D dose based on weight.

OTHER

Placebo

placebo with daily calcium/Vitamin D soft chews

Sponsors & Collaborators

• Children's Healthcare of Atlanta

  collaborator OTHER

• Emory University

  collaborator OTHER

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Ifeyinwa Osunkwo, MD, MPH · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-02-28

Primary Completion

2011-12-31

Completion

2013-12-31

FDA Drug

Yes

Countries

• United States

Study Locations