Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis

NCT01321905 | Completed

• 1 other identifier: 2009/1723-31/1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Parathyroid hormone (PTH)

  3 months

• Inflammatory parameters

  3 months

• Infection parameters

  3 months

• Lung function parameters

  3 months

• Glucose tolerance parameters

  3 months

Study Arms (3)

Ergocalciferol

EXPERIMENTAL

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.

Dietary Supplement: Supplementation with vitamin D2/D3

Cholecalciferol

EXPERIMENTAL

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.

Dietary Supplement: Supplementation with vitamin D2/D3

Control

NO INTERVENTION

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

Interventions

Supplementation with vitamin D2/D3 DIETARY_SUPPLEMENT

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.

Cholecalciferol; Ergocalciferol

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of cystic fibrosis
• Age 6 years and more
• Serum 25-hydroxy vitamin D concentration at the latest visit \< 75 nmol/L

You may not qualify if:

• 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
• Any known disorders of the endocrine system affecting vitamin D metabolism (hyperparathyroidism, malignancy, advanced renal disease)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Stockholm Cystic Fibrosis Center, Karolinska University Hospital Huddinge

Stockholm, 141 86, Sweden

Location

Related Publications (2)

• Pincikova T, Paquin-Proulx D, Sandberg JK, Flodstrom-Tullberg M, Hjelte L. Vitamin D treatment modulates immune activation in cystic fibrosis. Clin Exp Immunol. 2017 Sep;189(3):359-371. doi: 10.1111/cei.12984. Epub 2017 May 24.

  PMID: 28470739 DERIVED

• Pincikova T, Paquin-Proulx D, Sandberg JK, Flodstrom-Tullberg M, Hjelte L. Clinical impact of vitamin D treatment in cystic fibrosis: a pilot randomized, controlled trial. Eur J Clin Nutr. 2017 Feb;71(2):203-205. doi: 10.1038/ejcn.2016.259. Epub 2016 Dec 14.

  PMID: 27966575 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist, PhD

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: April 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

SE (1)