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NCT Number: NCT01321905

Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis

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.

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Key information

Conditions

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

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stockholm Cystic Fibrosis Center, Karolinska University Hospital Huddinge

Stockholm, 141 86, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Parathyroid hormone (PTH)

    Time frame: 3 months

    As a surrogate marker of bone health

  2. Inflammatory parameters

    Time frame: 3 months

    Cytokine profiles, antimicrobial peptides, peripheral blood mononuclear cell profiles, immunoglobulines, acute phase markers, sedimentation rate and other

  3. Infection parameters

    Time frame: 3 months

    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

  4. Lung function parameters

    Time frame: 3 months

    FEV1, FVC, PEF, FEF25, FEF50, FEF75 and other

  5. Glucose tolerance parameters

    Time frame: 3 months

    Insulin, C-peptide, glucagon, fasting plasma glucose, HbA1c, 3-hour 75-g oral glucose tolerance test

  6. Adherence with vitamin D treatment

    Time frame: 3 months

    Semi-quantitative assessment by a questionnaire (thus, a patient-reported outcome)

  7. Disease-specific quality of life

    Time frame: 3 months

    Assessment using "CFQ-R" questionnaire, specifically designed to measure the quality of life in CF patients

  8. Plasma calcium

    Time frame: 3 months

    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.

  9. Relative number of patients reaching high abnormal 25(OH)D concentrations

    Time frame: 3 months

    Proportion of patients in the intervention arms reaching 25(OH)D >250 nmol/L

  10. Proportion of patients reaching toxic 25(OH)D concentrations

    Time frame: 3 months

    Proportion of patients in the intervention arms reaching 25(OH)D >375 nmol/L

  11. Proportion of patients with suspect hypercalcaemia symptoms

    Time frame: 3 months

    Proportion of patients with suspect hypercalcaemia symptoms in the intervention arms

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

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

Acronym: D-vitamin

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 24, 2011
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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