Page Title
Clinical Trial Finder
Nutritional-GI Completed with Results
Vitamin D for enhancing the immune system in people with CF (TANGPR11A0)
This study evaluated the effect of a single high-dose of vitamin D3 given at the start of a pulmonary exacerbation followed by vitamin D3 maintenance treatment in adults with CF.
Participants, who were admitted to the hospital for an acute pulmonary exacerbation, were randomly assigned to receive either oral vitamin D3 (single dose of 250,000 International Units (IU)) or placebo within 72 hours of admission. Three months later, the participants who received vitamin D3 started taking 50,000 IU of vitamin D3 every two weeks for 12 months. Those that received placebo continued taking placebo every two weeks for 12 months.
Eligibility
-
Age:
16 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
20% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Results
-
What We Learned:
This study found that vitamin D3, given as described above, did not impact the length of time until a participant’s next pulmonary exacerbation or death within 1 year. Overall, vitamin D3 was well tolerated. However, more participants in the vitamin D3 group experienced a kidney-related adverse event than participants in the placebo group (N= 11 in vitamin D3 group and N=3 in placebo).
-
Primary Findings:
Effectiveness:
The study was conducted between January 2012 and April 2017. The study enrolled 91 participants (N=46 in the vitamin D3 group and N=45 in the placebo group).
The primary efficacy objective was a combination of time to next pulmonary exacerbation or death within 1 year. This study did not meet its primary objective. There was no difference between the vitamin D3 and placebo groups in time to next pulmonary exacerbation or death within 1 year.
No differences were seen in lung function recovery or in concentrations of the antimicrobial biomarker, cathelicidin, between the two groups. Serum vitamin D levels (25-OH vitamin D) were generally higher in the oral vitamin D group compared to the placebo group.
Safety:
Overall, vitamin D3 was well tolerated. However, more participants in the vitamin D3 group experienced a kidney-related adverse event than in the placebo group (N= 11 in vitamin D3 group and N=3 in placebo). The overall number of adverse events was not significantly different between the two groups.
-
Citation:
American Journal of Clinical Nutrition ;DOI 10.1093/ajcn/nqy291;1(109):544-553
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
1 years -
Number of Study Visits:
6
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Tangpricha, Vin -
Study Drugs:
N/A
Eligibility
-
Age:
16 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
20% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Sign up for clinical trial alerts
Get email updates about clinical trials that matter to you.
Check the Drug Development Pipeline
We’re attacking CF from every angle. Learn about the status of CF drugs in development.
Learn More