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

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
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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
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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 |
- 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 |
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

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
United States, Georgia | |
Emory University Hospital | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Vin Tangpricha, MD PhD | Emory University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Vin Tangpricha, MD, PH.D, Associate Professor of Medicine, Emory University |
ClinicalTrials.gov Identifier: | NCT01880346 |
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 |
Cystic Fibrosis Vitamin D absorption vitamin Deficiency fat soluble |
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 |