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

This study is currently recruiting participants.
Verified July 2011 by St. Michael's Hospital, Toronto
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00685971
First received: May 27, 2008
Last updated: June 8, 2012
Last verified: July 2011
History of Changes
  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 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:

U.S. FDA Resources

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
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685971

Contacts
Contact: Jennifer Pike 416-864-6060 ext 4109 pikej@smh.ca
Contact: Lesley Gaskin 416-864-6060 ext 4109 gaskinl@smh.ca

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

No publications provided

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: June 8, 2012
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on May 23, 2013