A randomized controlled trial of vitamin D replacement strategies in pediatric CF patients

J Cyst Fibros. 2016 Mar;15(2):234-41. doi: 10.1016/j.jcf.2015.07.004. Epub 2015 Jul 23.

Abstract

Background: Vitamin D insufficiency is common in children with cystic fibrosis (CF), yet data are sparse regarding the most effective form of vitamin D supplementation. The aim of this study was to compare two different vitamin D replacement regimens.

Methods: We conducted a randomized controlled trial comparing 50,000 IU of ergocalciferol (vitamin D2) twice weekly for 8 weeks versus 50,000 IU of cholecalciferol (vitamin D3) weekly in patients with CF, pancreatic insufficiency, age 6-21 years and a 25(OH)D<30 ng/mL. The primary outcome was change in serum 25(OH)D concentration. For secondary analyses, we examined changes in IgG, IgE and CRP in patients who normalized their vitamin D levels.

Results: A total of 47 patients completed the trial. The mean pre-treatment 25(OH)D concentration was 23.1 (SD 4.7) ng/mL. The overall mean increase in 25(OH)D was 11.1 (11.9) ng/mL and 31/47 (66%) achieved a 25(OH)D concentration ≥ 30 ng/mL; of the 26 participants who received D2, 18 (69%) achieved sufficiency while 13/21 (62%) participants treated with D3 achieved sufficiency. There was no difference between groups in change of 25(OH)D (p=0.65). Similarly, there was no difference in the number of patients to achieve vitamin D sufficiency between treatments (p=0.6).

Conclusions: Ergocalciferol administered as 50,000 IU twice weekly is as effective as cholecalciferol 50,000 IU weekly for 8 weeks in pediatric patients with CF and vitamin D insufficiency. Only 66% of the patients studied achieved the desired 25(OH)D concentration.

Keywords: Bone health; Cystic fibrosis; Nutrition; Pediatric; Vitamin D.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adolescent
  • Biomarkers / blood
  • Child
  • Cholecalciferol / administration & dosage*
  • Cystic Fibrosis / blood
  • Cystic Fibrosis / complications*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Ergocalciferols / administration & dosage*
  • Exocrine Pancreatic Insufficiency / blood
  • Exocrine Pancreatic Insufficiency / complications*
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Treatment Outcome
  • Vitamin D / analogs & derivatives
  • Vitamin D / blood
  • Vitamin D Deficiency / blood
  • Vitamin D Deficiency / drug therapy*
  • Vitamin D Deficiency / etiology
  • Vitamins / administration & dosage
  • Young Adult

Substances

  • Biomarkers
  • Ergocalciferols
  • Vitamins
  • Vitamin D
  • Cholecalciferol
  • 25-hydroxyvitamin D