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

Primary Purpose

Cystic Fibrosis

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Supplementation with vitamin D2/D3
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stockholm Cystic Fibrosis Center, Karolinska University Hospital HuddingeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Ergocalciferol

Cholecalciferol

Control

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Parathyroid hormone (PTH)
As a surrogate marker of bone health
Inflammatory parameters
Cytokine profiles, antimicrobial peptides, peripheral blood mononuclear cell profiles, immunoglobulines, acute phase markers, sedimentation rate and other
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
Lung function parameters
FEV1, FVC, PEF, FEF25, FEF50, FEF75 and other
Glucose tolerance parameters
Insulin, C-peptide, glucagon, fasting plasma glucose, HbA1c, 3-hour 75-g oral glucose tolerance test
Adherence with vitamin D treatment
Semi-quantitative assessment by a questionnaire (thus, a patient-reported outcome)
Disease-specific quality of life
Assessment using "CFQ-R" questionnaire, specifically designed to measure the quality of life in CF patients
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.
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
Proportion of patients reaching toxic 25(OH)D concentrations
Proportion of patients in the intervention arms reaching 25(OH)D >375 nmol/L
Proportion of patients with suspect hypercalcaemia symptoms
Proportion of patients with suspect hypercalcaemia symptoms in the intervention arms

Full Information

First Posted
March 23, 2011
Last Updated
March 23, 2011
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, Swedish Cystic Fibrosis Association
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1. Study Identification

Unique Protocol Identification Number
NCT01321905
Brief Title
Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis
Acronym
D-vitamin
Official Title
5-month Pilot Intervention Study on Vitamin D in Patients With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, Swedish Cystic Fibrosis Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ergocalciferol
Arm Type
Experimental
Arm 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.
Arm Title
Cholecalciferol
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients continue their ordinary vitamin supplementation without getting extra vitamin D supplements.
Intervention Type
Dietary Supplement
Intervention Name(s)
Supplementation with vitamin D2/D3
Intervention Description
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 Outcome Measure Information:
Title
Serum 25-hydroxy vitamin D
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Parathyroid hormone (PTH)
Description
As a surrogate marker of bone health
Time Frame
3 months
Title
Inflammatory parameters
Description
Cytokine profiles, antimicrobial peptides, peripheral blood mononuclear cell profiles, immunoglobulines, acute phase markers, sedimentation rate and other
Time Frame
3 months
Title
Infection parameters
Description
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
Time Frame
3 months
Title
Lung function parameters
Description
FEV1, FVC, PEF, FEF25, FEF50, FEF75 and other
Time Frame
3 months
Title
Glucose tolerance parameters
Description
Insulin, C-peptide, glucagon, fasting plasma glucose, HbA1c, 3-hour 75-g oral glucose tolerance test
Time Frame
3 months
Title
Adherence with vitamin D treatment
Description
Semi-quantitative assessment by a questionnaire (thus, a patient-reported outcome)
Time Frame
3 months
Title
Disease-specific quality of life
Description
Assessment using "CFQ-R" questionnaire, specifically designed to measure the quality of life in CF patients
Time Frame
3 months
Title
Plasma calcium
Description
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.
Time Frame
3 months
Title
Relative number of patients reaching high abnormal 25(OH)D concentrations
Description
Proportion of patients in the intervention arms reaching 25(OH)D >250 nmol/L
Time Frame
3 months
Title
Proportion of patients reaching toxic 25(OH)D concentrations
Description
Proportion of patients in the intervention arms reaching 25(OH)D >375 nmol/L
Time Frame
3 months
Title
Proportion of patients with suspect hypercalcaemia symptoms
Description
Proportion of patients with suspect hypercalcaemia symptoms in the intervention arms
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Terezia Pincikova, MD
Phone
+ 46 8 585 81483
Email
Terezia.Pincikova@karolinska.se
Facility Information:
Facility Name
Stockholm Cystic Fibrosis Center, Karolinska University Hospital Huddinge
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Hjelte, Professor
Phone
0046858587359
Email
Lena.Hjelte@karolinska.se

12. IPD Sharing Statement

Citations:
PubMed Identifier
28470739
Citation
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.
Results Reference
derived
PubMed Identifier
27966575
Citation
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.
Results Reference
derived

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Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis

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