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Comparison of Absorption of Vitamin D in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT01880346
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Vin Tangpricha, MD, PH.D, Emory University

Brief Summary:
The investigators predict that a powder pill form of vitamin D will be more effectively absorbed than an oil form of vitamin D in people diagnosed with Cystic Fibrosis.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Dietary Supplement: Vitamin D Powder Dietary Supplement: Vitamin D Oil Phase 4

Detailed Description:
The purpose of this study is to see how well two different forms of vitamin D work in Cystic Fibrosis (CF). Patients with Cystic Fibrosis have a hard time absorbing certain foods and often have low vitamin D levels. Studies show that vitamin D may help fight infections common in Cystic Fibrosis. The investigators would like to see if a powder pill form of vitamin D will work better than a pill mixed with oil. Each person will randomly receive either a powder pill or an oil based pill. Blood will be tested while during a 3-4 day hospital stay. The investigators plan to enroll no more than 24 patients with CF from Emory University Hospital for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vehicles for the Absorption of Vitamin D in Cystic Fibrosis: Comparison of Powder vs Oil
Study Start Date : October 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 100,000 IU D-50 powder
Vitamin D oil vs powder. 100,000 IU powder form of vitamin D, assessment of D3 absorption. One Dose of vitamin D powder format administered. Absorption rate monitored over 72 hour period
Dietary Supplement: Vitamin D Powder
Patients will be randomly assigned to a powder supplement of 100,000 IU vitamin D3. Randomization will be in blocks of 4 (meaning for every 4 subjects there will be 2 vitamin D and 2 placebo treated patients). Blood will be drawn by IV catheter at baseline, 2, 4, 8, 12, 24, 48, and 72 hours after vitamin D3 dosing
Other Name: D3-50 Cholecalciferol

Active Comparator: 100,000 IU Maximum D3 in oil
Vitamin D oil vs powder. One Dose of 100,000 IU vitamin D oil format administered. Absorption rate monitored over 72 hour period
Dietary Supplement: Vitamin D Oil
Patients will be randomly assigned to an oil based supplement of 100,000 IU vitamin D3. Randomization will be in blocks of 4 (meaning for every 4 subjects there will be 2 vitamin D and 2 placebo treated patients). Blood will be drawn by IV catheter at baseline, 2, 4, 8, 12, 24, 48, and 72 hours after vitamin D3 dosing
Other Name: Maximum D3




Primary Outcome Measures :
  1. Rate of Absorption of vitamin D3 to blood [ Time Frame: 72 hours ]
    rates of absorption of D3 will be compared for either an oil based or powder form pill OVER 72 HOURS.



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880346


Locations
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United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Vin Tangpricha, MD PhD Emory University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vin Tangpricha, MD, PH.D, Associate Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01880346     History of Changes
Other Study ID Numbers: IRB00066261
Hermes vitamin D ( Other Identifier: Tangpricha )
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Vin Tangpricha, MD, PH.D, Emory University:
Cystic Fibrosis
Vitamin D
absorption
vitamin Deficiency
fat soluble
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents