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

NCT00762918 | Withdrawn Phase 3 DMC

• 1 other identifier: 2007-12-5688
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cystic Fibrosis; Vitamin D Deficiency

Keywords

cystic fibrosis; vitamin d; inflammation

Outcome Measures

Primary Outcomes (1)

• serum 25-hydroxy vitamin D levels

  3 months

Secondary Outcomes (3)

• body composition

  3 months

• inflammatory markers

  3 months

• muscles strength

  3 months

Interventions

cholecalciferol DIETARY_SUPPLEMENT

cholecalciferol 5000 IU capsule by mouth daily for 3 months

Also known as: Vitamin D3

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects age 10-25 years
• cystic fibrosis
• (OH)-D \< 20 ng/mL
• FEV1 \> 40% -

You may not qualify if:

• inability to perform pulmonary function or hand-grip tests
• liver disease (including cirrhosis and portal hypertension) or baseline liver enzymes 21/2-fold greater than the upper limit of normal
• acute use of glucocorticoids at time of testing
• acute pulmonary exacerbation at time of testing
• known non-adherence to enzyme replacement
• hypercalcemia
• engages in "suntanning

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

MeSH Terms

Conditions

Cystic Fibrosis; Vitamin D Deficiency; Inflammation

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Andrea Kelly, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 22, 2010

Record last verified: 2010-02