5-month Pilot Intervention Study on Vitamin D in Patients With Cystic Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Serum 25-hydroxy vitamin D
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Serum 25-hydroxy vitamin D
Time Frame: 3 months
This pilot study is primarily designed for establishing effective vitamin D dosing in our specific patient population, and only secondarily designed (and thus, not powered for) for the secondary outcome measures. The results of this study will make it possible for the first time to power the follow-up long-term study for some of the secondary outcome measures followed in this pilot study, some of which might therefore become primary outcome measures in the follow-up study.
Secondary Outcomes
- Parathyroid hormone (PTH)(3 months)
- Inflammatory parameters(3 months)
- Infection parameters(3 months)
- Lung function parameters(3 months)
- Glucose tolerance parameters(3 months)
- Adherence with vitamin D treatment(3 months)
- Disease-specific quality of life(3 months)
- Plasma calcium(3 months)
- Relative number of patients reaching high abnormal 25(OH)D concentrations(3 months)
- Proportion of patients reaching toxic 25(OH)D concentrations(3 months)
- Proportion of patients with suspect hypercalcaemia symptoms(3 months)
Investigators
Terezia Pincikova
Pulmonologist, PhD
Karolinska Institutet