Trial | NCT01321905  Report issue

Title

Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis
5-month Pilot Intervention Study on Vitamin D in Patients With Cystic Fibrosis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    15
The vast majority of Cystic Fibrosis (CF) patients worldwide are vitamin D insufficient. There is no evidence of benefit of vitamin D supplementation for CF patients yet. However, descriptive cross-sectional studies suggest that vitamin D might be beneficial with respect to bone health, as well as to the newly described "non-classical" functions of vitamin D such as the potential anti-diabetic and immunomodulatory effects. To prove causation, and to determine which serum vitamin D concentration is optimal for CF patients, vitamin D supplementation interventional studies are needed, such as our trial.
Study Started
Apr 30
2010
Primary Completion
Sep 30
2011
Anticipated
Last Update
Mar 24
2011
Estimate

Dietary Supplement Supplementation with vitamin D2/D3

Patients younger than 16 years of age are administered 35,000 IU ergo-/chole-calciferol per week divided into doses 5000 IU per day as a starting dose that is further adjusted by serum 25-hydroxy vitamin D concentration monitoring. The intervention time is 3 months, followed by 2-months wash-out period when patients do not take any more extra vitamin D but they are still monitored. Patients 16 or more years of age are administered 50,000 IU ergo-/chole-calciferol per week divided into doses 7150 IU per day as a starting dose that is further adjusted by serum 25-hydroxy vitamin D concentration monitoring.

Ergocalciferol Experimental

Patients younger than 16 years of age are administered 35,000 IU ergocalciferol per week divided into doses 5000 IU per day as a starting dose that is further adjusted by serum 25-hydroxy vitamin D concentration monitoring. Patients 16 or more years of age are administered 50,000 IU ergocalciferol per week divided into doses 7150 IU per day as a starting dose that is further adjusted by serum 25-hydroxy vitamin D concentration monitoring.

Cholecalciferol Experimental

Patients younger than 16 years of age are administered 35,000 IU cholecalciferol per week divided into doses 5000 IU per day as a starting dose that is further adjusted by serum 25-hydroxy vitamin D concentration monitoring. Patients 16 or more years of age are administered 50,000 IU cholecalciferol per week divided into doses 7150 IU per day as a starting dose that is further adjusted by serum 25-hydroxy vitamin D concentration monitoring.

Control No Intervention

Patients continue their ordinary vitamin supplementation without getting extra vitamin D supplements.

Criteria 

Inclusion Criteria:

Established diagnosis of cystic fibrosis
Age 6 years and more
Serum 25-hydroxy vitamin D concentration at the latest visit < 75 nmol/L

Exclusion Criteria:

Pregnancy or lactation
Established diagnosis of CF-related diabetes
CF-related liver disease
Status post transplantation (lung, liver or other)
Long-term corticosteroid treatment per os
Hypercalcaemia or kidney stones
Use of tanning beds more often than once a month
At inclusion, plans to travel to a sunny location for more than 1 week during the study period
Any known disorders of the endocrine system affecting vitamin D metabolism (hyperparathyroidism, malignancy, advanced renal disease)
Inclusion into another study testing immunomodulatory substances
No Results Posted