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.

Abstract

Background: There is little consensus on the most efficacious vehicle substance for vitamin D supplements. Fat malabsorption may impede the ability of patients with cystic fibrosis (CF) to absorb vitamin D in an oil vehicle. We hypothesized that vitamin D contained in a powder vehicle would be absorbed more efficiently than vitamin D contained in an oil vehicle in patients with CF.

Methods: In this double-blind, randomized controlled trial, hospitalized adults with CF were given a one-time bolus dose of 100,000 IU of cholecalciferol (D3) in a powder-based or oil-based vehicle. Serum D3, 25-hydroxyvitamin D, and parathyroid hormone concentrations were analyzed at 0, 12, 24, and 48 hours posttreatment. The area under the curve for serum D3 and the 12-hour time point were also assessed as indicators of D3 absorption.

Results: This trial was completed by 15 patients with CF. The median (interquartile range) age, body mass index, and forced expiratory volume in 1 second were 23.7 (19.9-33.2) years, 19.9 (18.6-22.6) kg/m2, and 63% (37%-80%), respectively. The increase in serum D3 and the area under the curve was greater in the powder group ( P = .002 and P = .036, respectively). Serum D3 was higher at 12 hours in the powder group compared with the oil group ( P = .002), although levels were similar between groups by 48 hours.

Conclusions: In adults with CF, cholecalciferol is more efficiently absorbed in a powder compared with an oil vehicle. Physicians should consider prescribing vitamin D in a powder vehicle in patients with CF to improve the absorption of vitamin D from supplements.

Trial registration: ClinicalTrials.gov NCT01880346.

Keywords: cholecalciferol; cystic fibrosis; ergocalciferol; malabsorption; pancreatic insufficiency; vehicle; vitamin D; vitamin D3.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cholecalciferol / blood
  • Cystic Fibrosis / blood
  • Cystic Fibrosis / complications
  • Cystic Fibrosis / drug therapy*
  • Dietary Supplements
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Lipid Metabolism
  • Male
  • Parathyroid Hormone / blood
  • Pilot Projects
  • Powders
  • Prospective Studies
  • Treatment Outcome
  • Vitamin D / administration & dosage*
  • Vitamin D / blood*
  • Vitamin D Deficiency / drug therapy
  • Vitamin D Deficiency / etiology
  • Young Adult

Substances

  • Parathyroid Hormone
  • Powders
  • Vitamin D
  • Cholecalciferol

Associated data

  • ClinicalTrials.gov/NCT01880346