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Completed

NCT Number: NCT01880346

Comparison of Absorption of Vitamin D in Cystic Fibrosis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D Powder

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

Other names: D3-50 Cholecalciferol

Vitamin D Oil

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

Other names: Maximum D3

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 19, 2013
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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