Cholecalciferol for Vitamin D in Adult Cystic Fibrosis (CF) Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00685971
• Date of registration: 27/05/2008
• Prospective Registration: Yes
• Primary sponsor: St. Michael's Hospital, Toronto
• Public title: Cholecalciferol for Vitamin D in Adult Cystic Fibrosis (CF) Patients
• Scientific title: Randomized Placebo-Controlled Trial of Cholecalciferol for Vitamin D Deficiency in Adults With Cystic Fibrosis
• Date of first enrolment: December 2008
• Target sample size: 200
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00685971
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Anne Stephenson, Dr.
• Affiliation: St. Michael's Hospital, Toronto

Key inclusion & exclusion criteria

Inclusion Criteria:

1. older than 18 years of age

2. diagnosis of CF by sweat testing/genetics

3. vitamin D deficiency defined as a serum 25OHD level < 75 nmol/L

4. on stable baseline vitamin D supplementation for at least 2 months. Standard vitamin
D supplementation (cholecalciferol) in CF includes 800 IU daily for individuals with
pancreatic insufficiency and 400 IU daily for those with pancreatic sufficiency

Exclusion Criteria:

1. Individuals with known hypercalcemia or renal stones

2. psychiatric history

3. use of tanning beds/travel to sunny location within the last 2 months

4. lung transplantation

5. pregnancy or lactating women



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Vitamin D Deficiency

Intervention(s)

Dietary Supplement: placebo

Dietary Supplement: 5000 IU of cholecalciferol

Primary Outcome(s)

The primary outcome measure for this study is the change in mean serum 25OHD levels between the two groups [Time Frame: 12 weeks]

Secondary Outcome(s)

Mean change from baseline in parathyroid hormone levels [Time Frame: 12 weeks]

Mean change from baseline for pulmonary function testing (FEV1 and FVC) [Time Frame: 12 weeks]

A subgroup analysis by pancreatic status will be done to assess the impact of this factor on serum 25OHD levels [Time Frame: 12 weeks]

Change in the proportion of subjects whose 25OHD vitamin levels are above 75 nmol/L [Time Frame: 12 weeks]

Mean change from baseline in serum calcium levels [Time Frame: 12 weeks]

Mean change from baseline in creatinine levels [Time Frame: 12 weeks]

Secondary ID(s)

SMH 07-036

Source(s) of Monetary Support

Please refer to primary and secondary sponsors