Vitamin D3 for the Treatment of Low Vitamin D in Cystic Fibrosis

This study has been withdrawn prior to enrollment.
(Recruitment)
Sponsor:
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00762918
First received: September 26, 2008
Last updated: February 19, 2010
Last verified: February 2010
  Purpose

Vitamin D deficiency is common in cystic fibrosis. Vitamin D deficiency frequently persists despite aggressive treatment with ergocalciferol, a vitamin D preparation also known as vitamin D2. Cholecalciferol, a vitamin D preparation also known as vitamin D3,may work better to increase vitamin D levels.

Vitamin D is important for absorption of calcium from the diet and bone health. Vitamin D more recently has been found to play a role in regulating the normal inflammatory process. Since cystic fibrosis is a state of excessive inflammation, vitamin D may be playing a role in cystic fibrosis.

We hypothesize: cholecalciferol will work better to increase vitamin D levels in patients iwth cystic fibrosis and that it will have an effect on markers of inflammation.


Condition Intervention Phase
Cystic Fibrosis
Vitamin D Deficiency
Dietary Supplement: cholecalciferol
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin D and Its Non-Classic Roles in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • serum 25-hydroxy vitamin D levels [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • body composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • inflammatory markers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • muscles strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2008
Estimated Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: cholecalciferol
    cholecalciferol 5000 IU capsule by mouth daily for 3 months
    Other Name: Vitamin D3
Detailed Description:

Vitamin D deficiency is common in cystic fibrosis (CF) and persists despite relatively high doses of ergocalciferol, vitamin D2. Replacement has traditionally been focused upon maintenance of calcium and phosphorus homeostasis and bone health. However, non-classic roles of vitamin D have become increasingly recognized and the contribution of vitamin D deficiency to non-bone disorders has become apparent. Vitamin D deficiency has been associated with increased risk of a variety of cancers, autoimmune diseases such as Type 1 diabetes and multiple sclerosis, Type 2 diabetes, tuberculosis, and myopathy. The connection between vitamin D and these disease states likely reflects vitamin D's role as a transcriptional regulator: it participates in cell cycle regulation and in the innate immune system mediates cathelicidin production following activation of toll-like receptors.One hallmark of CF is pulmonary hyper-inflammation with recurrent infections. Additionally, malnutrition and decreased lean muscle mass threaten pulmonary function in CF. While vitamin D and its relation to bone has been explored in CF, the role of vitamin D in inflammation, lean body mass and strength, and pulmonary muscle strength has not been investigated. Moreover, vitamin D replacement has traditionally been with ergocalciferol, vitamin D2. Vitamin D3, cholecalciferol, has a longer half-life and is considered more potent. Thus, cholecalciferol treatment of children and young adults with CF and vitamin D deficiency may be useful for attaining normal vitamin D status and for exploring the impact of vitamin D upon lean body mass, pulmonary muscle strength, and inflammation.

  Eligibility

Ages Eligible for Study:   10 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects age 10-25 years
  2. cystic fibrosis
  3. 25-(OH)-D < 20 ng/mL
  4. FEV1 > 40% -

Exclusion Criteria:

  1. inability to perform pulmonary function or hand-grip tests
  2. liver disease (including cirrhosis and portal hypertension) or baseline liver enzymes 21/2-fold greater than the upper limit of normal
  3. acute use of glucocorticoids at time of testing
  4. acute pulmonary exacerbation at time of testing
  5. known non-adherence to enzyme replacement
  6. hypercalcemia
  7. engages in "suntanning
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00762918

Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Andrea Kelly, MD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Andrea Kelly, The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00762918     History of Changes
Other Study ID Numbers: 2007-12-5688
Study First Received: September 26, 2008
Last Updated: February 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
cystic fibrosis
vitamin d
inflammation

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
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2014