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

NCT ID: NCT00762918

Last Updated: 2010-02-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-09-30

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.

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.

Conditions

Cystic Fibrosis; Vitamin D Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cholecalciferol

cholecalciferol 5000 IU capsule by mouth daily for 3 months

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Vitamin D3

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

The Children's Hospital of Philadelphia

Principal Investigators

Andrea Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Other Identifiers

2007-12-5688

Identifier Type: -

Identifier Source: org_study_id