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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Karolinska Institutet.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Stockholm County Council, Sweden
Swedish Cystic Fibrosis Association
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01321905
First received: March 23, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
 Dietary Supplement: Supplementation with vitamin D2/D3
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 5-month Pilot Intervention Study on Vitamin D in Patients With Cystic Fibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Serum 25-hydroxy vitamin D [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Parathyroid hormone (PTH) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    As a surrogate marker of bone health

  • Inflammatory parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Cytokine profiles, antimicrobial peptides, peripheral blood mononuclear cell profiles, immunoglobulines, acute phase markers, sedimentation rate and other

  • Infection parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

  • Lung function parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    FEV1, FVC, PEF, FEF25, FEF50, FEF75 and other

  • Glucose tolerance parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Insulin, C-peptide, glucagon, fasting plasma glucose, HbA1c, 3-hour 75-g oral glucose tolerance test

  • Adherence with vitamin D treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Semi-quantitative assessment by a questionnaire (thus, a patient-reported outcome)

  • Disease-specific quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Assessment using "CFQ-R" questionnaire, specifically designed to measure the quality of life in CF patients

  • Plasma calcium [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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.

  • Relative number of patients reaching high abnormal 25(OH)D concentrations [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Proportion of patients in the intervention arms reaching 25(OH)D >250 nmol/L

  • Proportion of patients reaching toxic 25(OH)D concentrations [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Proportion of patients in the intervention arms reaching 25(OH)D >375 nmol/L

  • Proportion of patients with suspect hypercalcaemia symptoms [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Proportion of patients with suspect hypercalcaemia symptoms in the intervention arms


Estimated Enrollment: 15
Study Start Date: April 2010
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ergocalciferol

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

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.
Experimental: Cholecalciferol

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

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.
No Intervention: Control
Patients continue their ordinary vitamin supplementation without getting extra vitamin D supplements.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321905

Contacts
Contact: Terezia Pincikova, MD + 46 8 585 81483 Terezia.Pincikova@karolinska.se

Locations
Sweden
Stockholm Cystic Fibrosis Center, Karolinska University Hospital Huddinge Recruiting
Stockholm, Sweden, 141 86
Contact: Lena Hjelte, Professor     0046858587359     Lena.Hjelte@karolinska.se    
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Swedish Cystic Fibrosis Association
  More Information

No publications provided

Responsible Party: Amélie Theorell (Rector's secretary), Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01321905     History of Changes
Other Study ID Numbers: 2009/1723-31/1
Study First Received: March 23, 2011
Last Updated: March 23, 2011
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
 Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013