Pilot study of vitamin D supplementation in adults with cystic fibrosis pulmonary exacerbation: A randomized, controlled trial

Dermato-Endocrinology Volume 4, Issue 2 April/May/June 2012
Authors: Ruth E. Grossmann, Susu M. Zughaier, Meena Kumari, Shabnam Seydafkan, Robert H. Lyles, Shuling Liu, Viranuj Sueblinvong, Michael S. Schechter, Arlene A. Stecenko, Thomas R. Ziegler and Vin Tangpricha

Background: Vitamin D insufficiency is common in cystic fibrosis (CF) and vitamin D repletion may have an important role in improving clinical outcomes in CF. This randomized, placebo-controlled, pilot study examined the feasibility and impact of a single, large dose of cholecalciferol on vitamin D status and clinical outcomes in subjects with CF.

Methods: Thirty adults with were randomized in a double-blinded, pilot study to receive 250,000 IU cholecalciferol or placebo within 48 h of hospital admission for a pulmonary exacerbation. Concentrations of 25-hydroxyvitamin D (25(OH)D), clinical outcomes and potential adverse events were assessed up to 1-y after randomization. Mixed effects linear regression models were used to evaluate the difference in mean serum concentrations and log-rank analyses were used to evaluate survival.

Results: Data from all subjects was analyzed. Serum 25(OH)D concentrations increased from a mean of 30.6 ± 3.2 ng/mL to 58.1 ± 3.5 ng/mL (p < 0.001) at one week and 36.7 ± 2.6 ng/mL by 12 weeks (p = 0.06) in the vitamin D group; in contrast, serum 25(OH)D concentrations remained unchanged in the placebo group. Unadjusted, one-year survival and hospital-free days were increased in the vitamin D group (p = 0.029, p = 0.036; respectively). There was also a trend toward increased IV antibiotic therapy-free days in the vitamin D group (p = 0.073). There were no signs of hypervitaminosis D or adverse events. Serum PTH and calcium concentrations were similar across both groups.

Conclusions: In this pilot study, a single, oral bolus of cholecalciferol increased serum 25(OH)D concentrations and was associated with a trend toward improved clinical outcomes in CF subjects hospitalized for a pulmonary exacerbation. Further investigation is needed into the clinical impact of improved vitamin D status in patients with CF.

Approx 4X less risk of death due to single dose of Vitamin D

1 person in vitamin D group died vs 5 died in the placebo group

PDF is attached at the bottom of this page
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Wonder how many much less risk of death if vitamin D had been given multiple times.
Example: Give 250,000 IU vitamin D every 2 months.

Suspect that it will be difficult to get approval for a large CF RCT in the future.
The ethics committee would have a hard time allowing scores of CF deaths for the placebo group.

See also VitaminDWiki

• Category of Cystic Fibrosis 52 items
• Cystic fibrosis associated with low vitamin D – May 2012
• Overview Loading Doses of vitamin D
• Cystic fibrosis helped with single dose of 250,000 IU of vitamin D – RCT July 2012
  Same authors? same study, different publication
• 3800 IU of vitamin D is not enough for most children with cystic fibrosis – Aug 2012
• A type of vitamin D by Biotics Research for mal-absorption probably works for Cystic Fibrosis as well
• Is it ethical to not give vitamin D in osteoporosis trials? – NEJM Sept 2010
• Not enough women willing to stop taking vitamin D to permit breast cancer clinical trial – June 2012
• Review of Cystic Fibrosis and Vitamin D PDF file, not web page: which has the following figure