Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT01321905
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2011-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2011-03-23', 'studyFirstSubmitQcDate': '2011-03-23', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum 25-hydroxy vitamin D', 'timeFrame': '3 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Parathyroid hormone (PTH)', 'timeFrame': '3 months', 'description': 'As a surrogate marker of bone health'}, {'measure': 'Inflammatory parameters', 'timeFrame': '3 months', 'description': 'Cytokine profiles, antimicrobial peptides, peripheral blood mononuclear cell profiles, immunoglobulines, acute phase markers, sedimentation rate and other'}, {'measure': 'Infection parameters', 'timeFrame': '3 months', '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'}, {'measure': 'Lung function parameters', 'timeFrame': '3 months', 'description': 'FEV1, FVC, PEF, FEF25, FEF50, FEF75 and other'}, {'measure': 'Glucose tolerance parameters', 'timeFrame': '3 months', 'description': 'Insulin, C-peptide, glucagon, fasting plasma glucose, HbA1c, 3-hour 75-g oral glucose tolerance test'}, {'measure': 'Adherence with vitamin D treatment', 'timeFrame': '3 months', 'description': 'Semi-quantitative assessment by a questionnaire (thus, a patient-reported outcome)'}, {'measure': 'Disease-specific quality of life', 'timeFrame': '3 months', 'description': 'Assessment using "CFQ-R" questionnaire, specifically designed to measure the quality of life in CF patients'}, {'measure': 'Plasma calcium', 'timeFrame': '3 months', '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.'}, {'measure': 'Relative number of patients reaching high abnormal 25(OH)D concentrations', 'timeFrame': '3 months', 'description': 'Proportion of patients in the intervention arms reaching 25(OH)D \\>250 nmol/L'}, {'measure': 'Proportion of patients reaching toxic 25(OH)D concentrations', 'timeFrame': '3 months', 'description': 'Proportion of patients in the intervention arms reaching 25(OH)D \\>375 nmol/L'}, {'measure': 'Proportion of patients with suspect hypercalcaemia symptoms', 'timeFrame': '3 months', 'description': 'Proportion of patients with suspect hypercalcaemia symptoms in the intervention arms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '28470739', 'type': 'DERIVED', '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.'}, {'pmid': '27966575', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established diagnosis of cystic fibrosis\n* Age 6 years and more\n* Serum 25-hydroxy vitamin D concentration at the latest visit \\< 75 nmol/L\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Established diagnosis of CF-related diabetes\n* CF-related liver disease\n* Status post transplantation (lung, liver or other)\n* Long-term corticosteroid treatment per os\n* Hypercalcaemia or kidney stones\n* Use of tanning beds more often than once a month\n* At inclusion, plans to travel to a sunny location for more than 1 week during the study period\n* Any known disorders of the endocrine system affecting vitamin D metabolism (hyperparathyroidism, malignancy, advanced renal disease)\n* Inclusion into another study testing immunomodulatory substances'}, 'identificationModule': {'nctId': 'NCT01321905', 'acronym': 'D-vitamin', 'briefTitle': 'Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': '5-month Pilot Intervention Study on Vitamin D in Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': '2009/1723-31/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ergocalciferol', '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.\n\nPatients 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.', 'interventionNames': ['Dietary Supplement: Supplementation with vitamin D2/D3']}, {'type': 'EXPERIMENTAL', 'label': 'Cholecalciferol', '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.\n\nPatients 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.', 'interventionNames': ['Dietary Supplement: Supplementation with vitamin D2/D3']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients continue their ordinary vitamin supplementation without getting extra vitamin D supplements.'}], 'interventions': [{'name': 'Supplementation with vitamin D2/D3', 'type': 'DIETARY_SUPPLEMENT', '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.\n\nPatients 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.', 'armGroupLabels': ['Cholecalciferol', 'Ergocalciferol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Stockholm Cystic Fibrosis Center, Karolinska University Hospital Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pulmonologist, PhD', 'investigatorFullName': 'Terezia Pincikova', 'investigatorAffiliation': 'Karolinska Institutet'}}}}