Back to results

Comparison of Absorption of Vitamin D in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Vitamin D Powder

Vitamin D Oil

About this trial

This is an interventional prevention trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Vitamin D, absorption, vitamin Deficiency, fat soluble

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emory University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

100,000 IU D-50 powder

100,000 IU Maximum D3 in oil

Arm Description

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

Vitamin D oil vs powder. One Dose of 100,000 IU vitamin D oil format administered. Absorption rate monitored over 72 hour period

Outcomes

Primary Outcome Measures

Rate of Absorption of vitamin D3 to blood

rates of absorption of D3 will be compared for either an oil based or powder form pill OVER 72 HOURS.

Secondary Outcome Measures

Full Information

NCT ID

NCT01880346

First Posted

June 12, 2013

Last Updated

November 19, 2015

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT01880346

Brief Title

Comparison of Absorption of Vitamin D in Cystic Fibrosis

Official Title

Vehicles for the Absorption of Vitamin D in Cystic Fibrosis: Comparison of Powder vs Oil

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Cystic Fibrosis, Vitamin D, absorption, vitamin Deficiency, fat soluble

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

100,000 IU D-50 powder

Arm Type

Active Comparator

Arm Description

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

Arm Title

100,000 IU Maximum D3 in oil

Arm Type

Active Comparator

Arm Description

Vitamin D oil vs powder. One Dose of 100,000 IU vitamin D oil format administered. Absorption rate monitored over 72 hour period

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D Powder

Other Intervention Name(s)

D3-50 Cholecalciferol

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D Oil

Other Intervention Name(s)

Maximum D3

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of Absorption of vitamin D3 to blood

Description

rates of absorption of D3 will be compared for either an oil based or powder form pill OVER 72 HOURS.

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vin Tangpricha, MD PhD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22805498

Citation

Grossmann RE, Zughaier SM, Liu S, Lyles RH, Tangpricha V. Impact of vitamin D supplementation on markers of inflammation in adults with cystic fibrosis hospitalized for a pulmonary exacerbation. Eur J Clin Nutr. 2012 Sep;66(9):1072-4. doi: 10.1038/ejcn.2012.82. Epub 2012 Jul 18.

Results Reference

result

PubMed Identifier

22399505

Citation

Tangpricha V, Kelly A, Stephenson A, Maguiness K, Enders J, Robinson KA, Marshall BC, Borowitz D; Cystic Fibrosis Foundation Vitamin D Evidence-Based Review Committee. An update on the screening, diagnosis, management, and treatment of vitamin D deficiency in individuals with cystic fibrosis: evidence-based recommendations from the Cystic Fibrosis Foundation. J Clin Endocrinol Metab. 2012 Apr;97(4):1082-93. doi: 10.1210/jc.2011-3050. Epub 2012 Mar 7.

Results Reference

result

PubMed Identifier

12791627

Citation

Tangpricha V, Koutkia P, Rieke SM, Chen TC, Perez AA, Holick MF. Fortification of orange juice with vitamin D: a novel approach for enhancing vitamin D nutritional health. Am J Clin Nutr. 2003 Jun;77(6):1478-83. doi: 10.1093/ajcn/77.6.1478.

Results Reference

result

PubMed Identifier

1550069

Citation

Johnson EJ, Krasinski SD, Howard LJ, Alger SA, Dutta SK, Russell RM. Evaluation of vitamin A absorption by using oil-soluble and water-miscible vitamin A preparations in normal adults and in patients with gastrointestinal disease. Am J Clin Nutr. 1992 Apr;55(4):857-64. doi: 10.1093/ajcn/55.4.857.

Results Reference

result

PubMed Identifier

8125859

Citation

Roum JH, Buhl R, McElvaney NG, Borok Z, Crystal RG. Systemic deficiency of glutathione in cystic fibrosis. J Appl Physiol (1985). 1993 Dec;75(6):2419-24. doi: 10.1152/jappl.1993.75.6.2419.

Results Reference

result

PubMed Identifier

14717616

Citation

Hecker TM, Aris RM. Management of osteoporosis in adults with cystic fibrosis. Drugs. 2004;64(2):133-47. doi: 10.2165/00003495-200464020-00002.

Results Reference

result

PubMed Identifier

26903303

Citation

Hermes WA, Alvarez JA, Lee MJ, Chesdachai S, Lodin D, Horst R, Tangpricha V. Prospective, Randomized, Double-Blind, Parallel-Group, Comparative Effectiveness Clinical Trial Comparing a Powder Vehicle Compound of Vitamin D With an Oil Vehicle Compound in Adults With Cystic Fibrosis. JPEN J Parenter Enteral Nutr. 2017 Aug;41(6):952-958. doi: 10.1177/0148607116629673. Epub 2016 Feb 22.

Results Reference

derived

Learn more about this trial

Comparison of Absorption of Vitamin D in Cystic Fibrosis

We'll reach out to this number within 24 hrs