Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis (D-vitamin)

Karolinska Institute

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Dietary Supplement: Supplementation with vitamin D2/D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01321905

2009/1723-31/1

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Ergocalciferol

Experimental group

Description:

Patients younger than 16 years of age are administered 35,000 IU ergocalciferol 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. Patients 16 or more years of age are administered 50,000 IU ergocalciferol 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.

Treatment:

Dietary Supplement: Supplementation with vitamin D2/D3

Cholecalciferol

Experimental group

Description:

Patients younger than 16 years of age are administered 35,000 IU cholecalciferol 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. Patients 16 or more years of age are administered 50,000 IU cholecalciferol 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.

Treatment:

Dietary Supplement: Supplementation with vitamin D2/D3

Control

No Intervention group

Description:

Patients continue their ordinary vitamin supplementation without getting extra vitamin D supplements.