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Comparison of Absorption of Vitamin D in Cystic Fibrosis

NCT ID: NCT01880346

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Vitamin D Powder

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type ACTIVE_COMPARATOR

Vitamin D Oil

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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D3-50 Cholecalciferol Maximum D3

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Vin Tangpricha, MD, PH.D

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vin Tangpricha, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22805498 (View on PubMed)

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.

Reference Type RESULT
PMID: 22399505 (View on PubMed)

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.

Reference Type RESULT
PMID: 12791627 (View on PubMed)

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.

Reference Type RESULT
PMID: 1550069 (View on PubMed)

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.

Reference Type RESULT
PMID: 8125859 (View on PubMed)

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

Reference Type RESULT
PMID: 14717616 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26903303 (View on PubMed)

Other Identifiers

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Hermes vitamin D

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00066261

Identifier Type: -

Identifier Source: org_study_id