Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01321905
• Date of registration: 23/03/2011
• Prospective Registration: No
• Primary sponsor: Karolinska Institutet
• Public title: Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis D-vitamin
• Scientific title: 5-month Pilot Intervention Study on Vitamin D in Patients With Cystic Fibrosis
• Date of first enrolment: April 2010
• Target sample size: 15
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01321905
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Sweden

Contacts

• Name: Terezia Pincikova, MD

• Name: Lena Hjelte, Professor

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Dietary Supplement: Supplementation with vitamin D2/D3

Primary Outcome(s)

Serum 25-hydroxy vitamin D [Time Frame: 3 months]

Secondary Outcome(s)

Proportion of patients with suspect hypercalcaemia symptoms [Time Frame: 3 months]

Parathyroid hormone (PTH) [Time Frame: 3 months]

Plasma calcium [Time Frame: 3 months]

Infection parameters [Time Frame: 3 months]

Inflammatory parameters [Time Frame: 3 months]

Adherence with vitamin D treatment [Time Frame: 3 months]

Glucose tolerance parameters [Time Frame: 3 months]

Proportion of patients reaching toxic 25(OH)D concentrations [Time Frame: 3 months]

Relative number of patients reaching high abnormal 25(OH)D concentrations [Time Frame: 3 months]

Disease-specific quality of life [Time Frame: 3 months]

Lung function parameters [Time Frame: 3 months]

Secondary ID(s)

2009/1723-31/1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Stockholm County Council, Sweden

Swedish Cystic Fibrosis Association