Cystic FibrosisD-vitaminNCT01321905
Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis
A study testing Supplementation with vitamin D2/D3 in people with Cystic Fibrosis, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Supplementation with vitamin D2/D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Established diagnosis of cystic fibrosis
- Age 6 years and more
- Serum 25-hydroxy vitamin D concentration at the latest visit < 75 nmol/L
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Sweden1 site
Stockholm Cystic Fibrosis Center, Karolinska University Hospital Huddinge
Stockholm, 141 86
About this study
Official title: 5-month Pilot 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Supplementation with vitamin D2/D3
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation with vitamin D2/D3Dietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Supplementation with vitamin D2/D3 |
| Control | No intervention | Patients continue their ordinary vitamin supplementation without getting extra vitamin D supplements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (11)
Parathyroid hormone (PTH)
As a surrogate marker of bone health
Measured: 3 months
Inflammatory parameters
Cytokine profiles, antimicrobial peptides, peripheral blood mononuclear cell profiles, immunoglobulines, acute phase markers, sedimentation rate and other
Measured: 3 months
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
Measured: 3 months
Lung function parameters
FEV1, FVC, PEF, FEF25, FEF50, FEF75 and other
Measured: 3 months
Glucose tolerance parameters
Insulin, C-peptide, glucagon, fasting plasma glucose, HbA1c, 3-hour 75-g oral glucose tolerance test
Measured: 3 months
Adherence with vitamin D treatment
Semi-quantitative assessment by a questionnaire (thus, a patient-reported outcome)
Measured: 3 months
Disease-specific quality of life
Assessment using "CFQ-R" questionnaire, specifically designed to measure the quality of life in CF patients
Measured: 3 months
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.
Measured: 3 months
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
Measured: 3 months
Proportion of patients reaching toxic 25(OH)D concentrations
Proportion of patients in the intervention arms reaching 25(OH)D >375 nmol/L
Measured: 3 months
Proportion of patients with suspect hypercalcaemia symptoms
Proportion of patients with suspect hypercalcaemia symptoms in the intervention arms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Terezia Pincikova, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321905
- Sponsor's protocol ID
- 2009/1723-31/1
- Acronym
- D-vitamin
- Status last verified
- Oct 2024
- First submitted
- 23 Mar 2011
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28470739Pincikova 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.
PubMed 27966575
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-month Pilot Intervention Study on Vitamin D in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01321905
- Acronym / sponsor ID
- D-vitamin / 2009/1723-31/1
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ergocalciferol | Experimental | Dietary Supplement: Supplementation with vitamin D2/D3Patients 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. |
| Cholecalciferol | Experimental | Dietary Supplement: Supplementation with vitamin D2/D3Patients 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. |
| Control | No intervention | –Patients continue their ordinary vitamin supplementation without getting extra vitamin D supplements. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Established diagnosis of cystic fibrosis
- Age 6 years and more
- Serum 25-hydroxy vitamin D concentration at the latest visit < 75 nmol/L
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplementation with vitamin D2/D3Patients 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. | Dietary supplement | Cholecalciferol, Ergocalciferol |
Primary outcome
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.
11 secondary outcomes
Parathyroid hormone (PTH)
Time frame: 3 months
Inflammatory parameters
Time frame: 3 months
Infection parameters
Time frame: 3 months
Lung function parameters
Time frame: 3 months
Glucose tolerance parameters
Time frame: 3 months
Adherence with vitamin D treatment
Time frame: 3 months
Disease-specific quality of life
Time frame: 3 months
Plasma calcium
Time frame: 3 months
Relative number of patients reaching high abnormal 25(OH)D concentrations
Time frame: 3 months
Proportion of patients reaching toxic 25(OH)D concentrations
Time frame: 3 months
Proportion of patients with suspect hypercalcaemia symptoms
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 28470739Pincikova 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.
- Derived from this study: PubMed 27966575Pincikova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplementation with vitamin D2/D3 in people with Cystic Fibrosis, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25-hydroxy vitamin D (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01321905, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.