NCT01880346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

1.4 years

First QC Date

June 12, 2013

Last Update Submit

November 19, 2015

Conditions

Cystic Fibrosis

Keywords

Cystic FibrosisVitamin Dabsorptionvitamin Deficiencyfat soluble

Outcome Measures

Primary Outcomes (1)

  • 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.

    72 hours

Study Arms (2)

100,000 IU D-50 powder

ACTIVE COMPARATOR

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

100,000 IU Maximum D3 in oil

ACTIVE COMPARATOR

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

Interventions

Vitamin D PowderDIETARY_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

Also known as: D3-50 Cholecalciferol
100,000 IU D-50 powder
Vitamin D OilDIETARY_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

Also known as: Maximum D3
100,000 IU Maximum D3 in oil

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult CF patients (age \>18 years
  • Able to tolerate oral medication
  • Expected to survive the duration of the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (7)

  • 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.

    PMID: 22805498RESULT

  • 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.

    PMID: 22399505RESULT

  • 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.

    PMID: 12791627RESULT

  • 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.

    PMID: 1550069RESULT

  • 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.

    PMID: 8125859RESULT

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

    PMID: 14717616RESULT

  • 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.

    PMID: 26903303DERIVED

MeSH Terms

Conditions

Cystic FibrosisAvitaminosis

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Vin Tangpricha, MD PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 12, 2013

First Posted

June 19, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2015

Study Completion

October 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

US(1)