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

Cystic Fibrosis Clinical Trial

Official title:

Vitamin D and Its Non-Classic Roles in Cystic Fibrosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00762918
• Other study ID #: 2007-12-5688
• Status: Withdrawn
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: February 19, 2010
• Start date: March 2008
• Est. completion date: September 2008

Study information

• Verified date: February 2010
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 25 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• cholecalciferol
cholecalciferol 5000 IU capsule by mouth daily for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum 25-hydroxy vitamin D levels		3 months	Yes
Secondary	body composition		3 months	No
Secondary	inflammatory markers		3 months	No
Secondary	muscles strength		3 months	No