Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— D-vitamin  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01321905
• Other study ID #: 2009/1723-31/1
• Status: Recruiting
• Phase: Phase 2
• First received: March 23, 2011
• Last updated: March 23, 2011
• Start date: April 2010

Study information

• Verified date: March 2011
• Source: Karolinska Institutet
• Contact: Terezia Pincikova, MD
• Phone: + 46 8 585 81483
• Email: Terezia.Pincikova[@]karolinska.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.

Locations

Country	Name	City	State
Sweden	Stockholm Cystic Fibrosis Center, Karolinska University Hospital Huddinge	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden, Swedish Cystic Fibrosis Association

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25-hydroxy vitamin D	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.	3 months	No
Secondary	Parathyroid hormone (PTH)	As a surrogate marker of bone health	3 months	No
Secondary	Inflammatory parameters	Cytokine profiles, antimicrobial peptides, peripheral blood mononuclear cell profiles, immunoglobulines, acute phase markers, sedimentation rate and other	3 months	No
Secondary	Infection parameters	Number of days on intravenous antibiotic treatment; number of infectious episodes; number of common cold episodes; relative number of sputum samples positive for pathological bacteria; and other	3 months	No
Secondary	Lung function parameters	FEV1, FVC, PEF, FEF25, FEF50, FEF75 and other	3 months	No
Secondary	Glucose tolerance parameters	Insulin, C-peptide, glucagon, fasting plasma glucose, HbA1c, 3-hour 75-g oral glucose tolerance test	3 months	No
Secondary	Adherence with vitamin D treatment	Semi-quantitative assessment by a questionnaire (thus, a patient-reported outcome)	3 months	No
Secondary	Disease-specific quality of life	Assessment using "CFQ-R" questionnaire, specifically designed to measure the quality of life in CF patients	3 months	No
Secondary	Plasma calcium	Proportion of patients with albumin-corrected serum calcium increasing to a concentration greater than 2,75 mmol/L in patients with no hypercalcaemia before vitamin D supplementation was started.	3 months	Yes
Secondary	Relative number of patients reaching high abnormal 25(OH)D concentrations	Proportion of patients in the intervention arms reaching 25(OH)D >250 nmol/L	3 months	Yes
Secondary	Proportion of patients reaching toxic 25(OH)D concentrations	Proportion of patients in the intervention arms reaching 25(OH)D >375 nmol/L	3 months	Yes
Secondary	Proportion of patients with suspect hypercalcaemia symptoms	Proportion of patients with suspect hypercalcaemia symptoms in the intervention arms	3 months	Yes