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NCT01331148 · ClinicalTrials.gov registry record · Phase 2
High Dose Vitamin D for Sickle Cell Disease
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT01331148 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 46 participants.
The verdict
NCT01331148, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- DRUG Vitamin D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01331148
The ClinicalTrials.gov registry entry for NCT01331148 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01331148 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01331148 about?
NCT01331148 is a clinical study titled "High Dose Vitamin D for Sickle Cell Disease". 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 investigator...
What is the current status of trial NCT01331148?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2009-02. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01331148?
The interventions under investigation include: Placebo (OTHER), Vitamin D (DRUG).
Who is sponsoring clinical trial NCT01331148?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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