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Cholecalciferol for Vitamin D in Adult Cystic Fibrosis (CF) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00685971
First received: May 27, 2008
Last updated: November 20, 2014
Last verified: July 2011
  Purpose
The main aim of the research question to test the primary hypothesis of this study, namely, Does 12 weeks of an additional 5000 IU daily of cholecalciferol increase serum 25OHD levels in adults with Cystic Fibrosis (CF) who have vitamin D deficiency relative to placebo?

Condition Intervention
Cystic Fibrosis
Vitamin D Deficiency
Dietary Supplement: 5000 IU of cholecalciferol
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Placebo-Controlled Trial of Cholecalciferol for Vitamin D Deficiency in Adults With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • The primary outcome measure for this study is the change in mean serum 25OHD levels between the two groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline for pulmonary function testing (FEV1 and FVC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in serum calcium levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in parathyroid hormone levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in creatinine levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in the proportion of subjects whose 25OHD vitamin levels are above 75 nmol/L [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • A subgroup analysis by pancreatic status will be done to assess the impact of this factor on serum 25OHD levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
vitamin
Dietary Supplement: 5000 IU of cholecalciferol
5 drops taken once daily for 12 weeks
Placebo Comparator: Placebo Dietary Supplement: placebo
5 drops once daily for 12 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. older than 18 years of age
  2. diagnosis of CF by sweat testing/genetics
  3. vitamin D deficiency defined as a serum 25OHD level < 75 nmol/L
  4. on stable baseline vitamin D supplementation for at least 2 months. Standard vitamin D supplementation (cholecalciferol) in CF includes 800 IU daily for individuals with pancreatic insufficiency and 400 IU daily for those with pancreatic sufficiency

Exclusion Criteria:

  1. Individuals with known hypercalcemia or renal stones
  2. psychiatric history
  3. use of tanning beds/travel to sunny location within the last 2 months
  4. lung transplantation
  5. pregnancy or lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685971

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Anne Stephenson, Dr. St. Michael's Hospital, Toronto
  More Information

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00685971     History of Changes
Other Study ID Numbers: SMH 07-036 
Study First Received: May 27, 2008
Last Updated: November 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
Cystic Fibrosis
Vitamin D deficiency

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

ClinicalTrials.gov processed this record on September 26, 2016