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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00685971
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : November 21, 2014
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Vitamin D Deficiency Dietary Supplement: 5000 IU of cholecalciferol Dietary Supplement: placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Placebo-Controlled Trial of Cholecalciferol for Vitamin D Deficiency in Adults With Cystic Fibrosis
Study Start Date : December 2008
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: Vitamin D
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

Primary Outcome Measures :
  1. The primary outcome measure for this study is the change in mean serum 25OHD levels between the two groups [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Mean change from baseline for pulmonary function testing (FEV1 and FVC) [ Time Frame: 12 weeks ]
  2. Mean change from baseline in serum calcium levels [ Time Frame: 12 weeks ]
  3. Mean change from baseline in parathyroid hormone levels [ Time Frame: 12 weeks ]
  4. Mean change from baseline in creatinine levels [ Time Frame: 12 weeks ]
  5. Change in the proportion of subjects whose 25OHD vitamin levels are above 75 nmol/L [ Time Frame: 12 weeks ]
  6. A subgroup analysis by pancreatic status will be done to assess the impact of this factor on serum 25OHD levels [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00685971

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

Responsible Party: St. Michael's Hospital, Toronto Identifier: NCT00685971     History of Changes
Other Study ID Numbers: SMH 07-036
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: July 2011

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

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