Clinical trial NCT01321905: Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis
Official title: 5-month Pilot Intervention Study on Vitamin D in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2011-03-24
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Serum 25-hydroxy vitamin D
timeFrame: 3 months
Secondary outcomes:
measure: Parathyroid hormone (PTH)
timeFrame: 3 months
measure: Inflammatory parameters
timeFrame: 3 months
measure: Infection parameters
timeFrame: 3 months
measure: Lung function parameters
timeFrame: 3 months
measure: Glucose tolerance parameters
timeFrame: 3 months
measure: Adherence with vitamin D treatment
timeFrame: 3 months
measure: Disease-specific quality of life
timeFrame: 3 months
measure: Plasma calcium
timeFrame: 3 months
measure: Relative number of patients reaching high abnormal 25(OH)D concentrations
timeFrame: 3 months
measure: Proportion of patients reaching toxic 25(OH)D concentrations
timeFrame: 3 months
measure: Proportion of patients with suspect hypercalcaemia symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholm Cystic Fibrosis Center, Karolinska University Hospital Huddinge
Study officials:
References:
citation: Pincikova T, Paquin-Proulx D, Sandberg JK, Flodstrom-Tullberg M, Hjelte L. Vitamin D treatment modulates immune activation in cystic fibrosis. Clin Exp Immunol. 2017 Sep;189(3):359-371. doi: 10.1111/cei.12984. Epub 2017 May 24.
citation: Pincikova T, Paquin-Proulx D, Sandberg JK, Flodstrom-Tullberg M, Hjelte L. Clinical impact of vitamin D treatment in cystic fibrosis: a pilot randomized, controlled trial. Eur J Clin Nutr. 2017 Feb;71(2):203-205. doi: 10.1038/ejcn.2016.259. Epub 2016 Dec 14.