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

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00762918

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis Vitamin D Deficiency	Dietary Supplement: cholecalciferol	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Vitamin D and Its Non-Classic Roles in Cystic Fibrosis

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Sep 1, 2008

Anticipated Study Completion Date :

Sep 1, 2008

Outcome Measures

Primary Outcome Measures

serum 25-hydroxy vitamin D levels [3 months]

Secondary Outcome Measures

body composition [3 months]
inflammatory markers [3 months]
muscles strength [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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