Vitamin D3 for the Treatment of Low Vitamin D in Cystic Fibrosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00762918|
Recruitment Status : Withdrawn (Recruitment)
First Posted : September 30, 2008
Last Update Posted : February 22, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Vitamin D Deficiency||Dietary Supplement: cholecalciferol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vitamin D and Its Non-Classic Roles in Cystic Fibrosis|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||September 2008|
|Estimated Study Completion Date :||September 2008|
- Dietary Supplement: cholecalciferol
cholecalciferol 5000 IU capsule by mouth daily for 3 monthsOther Name: Vitamin D3
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762918
|Principal Investigator:||Andrea Kelly, MD||Children's Hospital of Philadelphia|