|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
7 December 2015 |
|
Main ID: |
NCT01880346 |
|
Date of registration:
|
12/06/2013 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Comparison of Absorption of Vitamin D in Cystic Fibrosis
|
|
Scientific title:
|
Vehicles for the Absorption of Vitamin D in Cystic Fibrosis: Comparison of Powder vs Oil |
|
Date of first enrolment:
|
October 2013 |
|
Target sample size:
|
17 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01880346 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Vin Tangpricha, MD PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Emory University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Adult CF patients (age >18 years
- Able to tolerate oral medication
- Expected to survive the duration of the study
Exclusion Criteria:
- Inability to obtain or declined informed consent from the subject and/or legally
authorized representative
- History of disorders associated with hypercalcemia
- Current hypercalcemia (albumin-corrected serum calcium >10.8 mg/dL or ionized calcium
>5.2 mg/dL)
- Chronic kidney disease worse than stage III (<60 ml/min), 7) Forced Expiratory Volume
(FEV1)% predicted <20%
- Current significant hepatic dysfunction total bilirubin > 2.5 mg/dL with direct
bilirubin > 1.0 mg/dL
- Current use of cytotoxic or immunosuppressive drugs
- History of AIDS or illicit drug abuse
- too ill to participate in study based on investigator's or study team's opinion
- current enrollment in another intervention trial
Age minimum:
18 Years
Age maximum:
59 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Cystic Fibrosis
|
|
Intervention(s)
|
|
Dietary Supplement: Vitamin D Powder
|
|
Dietary Supplement: Vitamin D Oil
|
|
Primary Outcome(s)
|
|
Rate of Absorption of vitamin D3 to blood
[Time Frame: 72 hours]
|
|
Secondary ID(s)
|
|
IRB00066261
|
|
Hermes vitamin D
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|