Vitamin D3 for the Treatment of Low Vitamin D in Cystic Fibrosis
Vitamin D deficiency is common in cystic fibrosis. Vitamin D deficiency frequently persists despite aggressive treatment with ergocalciferol, a vitamin D preparation also known as vitamin D2. Cholecalciferol, a vitamin D preparation also known as vitamin D3,may work better to increase vitamin D levels.
Vitamin D is important for absorption of calcium from the diet and bone health. Vitamin D more recently has been found to play a role in regulating the normal inflammatory process. Since cystic fibrosis is a state of excessive inflammation, vitamin D may be playing a role in cystic fibrosis.
We hypothesize: cholecalciferol will work better to increase vitamin D levels in patients iwth cystic fibrosis and that it will have an effect on markers of inflammation.
|Cystic Fibrosis Vitamin D Deficiency||Dietary Supplement: cholecalciferol||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Vitamin D and Its Non-Classic Roles in Cystic Fibrosis|
- serum 25-hydroxy vitamin D levels [ Time Frame: 3 months ]
- body composition [ Time Frame: 3 months ]
- inflammatory markers [ Time Frame: 3 months ]
- muscles strength [ Time Frame: 3 months ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Dietary Supplement: cholecalciferol
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762918
|Principal Investigator:||Andrea Kelly, MD||Children's Hospital of Philadelphia|