Vitamin D and prebiotics for intestinal health in cystic fibrosis: Rationale and design for a randomized, placebo-controlled, double-blind, 2 x 2 trial of administration of prebiotics and cholecalciferol (vitamin D<inf>3</inf>) (Pre-D trial) in adults with cystic fibrosis
2
Issued Date
2024-04-01
Resource Type
ISSN
24518654
Scopus ID
2-s2.0-85185781906
Journal Title
Contemporary Clinical Trials Communications
Volume
38
Rights Holder(s)
SCOPUS
Bibliographic Citation
Contemporary Clinical Trials Communications Vol.38 (2024)
Suggested Citation
Sivapiromrat A.K., Suppakitjanusant P., Wang Y., Hu C., Binongo J., Hunt W.R., Weinstein S., Jathal I., Alvarez J.A., Chassaing B., Ziegler T.R., Gewirtz A.T., Tangpricha V. Vitamin D and prebiotics for intestinal health in cystic fibrosis: Rationale and design for a randomized, placebo-controlled, double-blind, 2 x 2 trial of administration of prebiotics and cholecalciferol (vitamin D<inf>3</inf>) (Pre-D trial) in adults with cystic fibrosis. Contemporary Clinical Trials Communications Vol.38 (2024). doi:10.1016/j.conctc.2024.101278 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/97426
Title
Vitamin D and prebiotics for intestinal health in cystic fibrosis: Rationale and design for a randomized, placebo-controlled, double-blind, 2 x 2 trial of administration of prebiotics and cholecalciferol (vitamin D<inf>3</inf>) (Pre-D trial) in adults with cystic fibrosis
Corresponding Author(s)
Other Contributor(s)
Abstract
Individuals with cystic fibrosis (CF) have dysfunctional intestinal microbiota and increased gastrointestinal (GI) inflammation also known as GI dysbiosis. It is hypothesized that administration of high-dose cholecalciferol (vitamin D3) together with a prebiotic (inulin) will be effective, and possibly additive or synergistic, in reducing CF-related GI and airway dysbiosis. Thus, a 2 x 2 factorial design, placebo-controlled, double-blinded, pilot and feasibility, clinical trial was proposed to test this hypothesis. Forty adult participants with CF were block-randomized into one of four groups: 1) high-dose oral vitamin D3 (50,000 IU weekly) plus oral prebiotic placebo daily; 2) oral prebiotic (12 g inulin daily) plus oral placebo vitamin D3 weekly; 3) combined oral vitamin D3 weekly and oral prebiotic inulin daily; and 4) oral vitamin D3 placebo weekly and oral prebiotic placebo. The primary endpoints included 12-week changes in the microbial bacterial communities, gut and airway microbiota richness and diversity before and after the intervention. This pilot study examined whether vitamin D3 with or without prebiotics supplementation was feasible, changed airway and gut microbiota, and reduced dysbiosis, which in turn, may improve health outcomes and quality of life of patients with CF.