Effect of vitamin D supplementation on cystic fibrosis pulmonary exacerbations: A pilot randomized crossover clinical trial

Summary: Background & Aims: Control of pulmonary exacerbations (PEs) is highly important in the treatment of cystic fibrosis (CF). Given the evidence of the extra skeletal properties of vitamin D, this study aimed to evaluate the effect of supplementation with an extra dose of vitamin D on...

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Main Authors: Renata Ongaratto, Frederico Orlando Friedrich, Gabriele Carra Forte, Gabriela de Azevedo Bastian de Souza, Sofia Prates da Cunha de Azevedo, Laura Gomes Boabaid de Barros, Leonardo Araujo Pinto
Format: Article
Language:English
Published: Elsevier 2024-04-01
Series:Clinical Nutrition Open Science
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2667268524000123
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author Renata Ongaratto
Frederico Orlando Friedrich
Gabriele Carra Forte
Gabriela de Azevedo Bastian de Souza
Sofia Prates da Cunha de Azevedo
Laura Gomes Boabaid de Barros
Leonardo Araujo Pinto
author_facet Renata Ongaratto
Frederico Orlando Friedrich
Gabriele Carra Forte
Gabriela de Azevedo Bastian de Souza
Sofia Prates da Cunha de Azevedo
Laura Gomes Boabaid de Barros
Leonardo Araujo Pinto
author_sort Renata Ongaratto
collection DOAJ
description Summary: Background & Aims: Control of pulmonary exacerbations (PEs) is highly important in the treatment of cystic fibrosis (CF). Given the evidence of the extra skeletal properties of vitamin D, this study aimed to evaluate the effect of supplementation with an extra dose of vitamin D on CF PEs. Methods: This is a randomized crossover clinical trial conducted in Brazil. Subjects were randomly allocated to receive vitamin D (5,000-10,000 IU/day, liquid, or gelatin capsules) followed by standard treatment (400-2,000 IU/day of vitamin D), or standard treatment followed by vitamin D for three months, with 9-month washout separating each treatment period. The primary endpoint was the number of PEs during the intervention period. In addition, a 6-month period following the use of the extra dose and the regular dose were assessed. Secondary outcome included change in serum 25(OH)D after the end of supplementation. Results: 34 subjects completed the study (16 received vitamin D first, and 18 received standard treatment first; median age: 5.16 years (1.74:8.07)). A significant statistical reduction in pulmonary exacerbations with the use of the extra dose of vitamin D was not detected (P = 0.10). No effect of vitamin D on PEs was observed after the end of supplementation. More than half of the subjects had suboptimal levels of 25(OH)D pre-supplementation and only 58% achieved desirable levels of the vitamin. Conclusion: Our findings reinforce the high prevalence of hypovitaminosis D in subjects with CF, despite routine supplementation. Further robust evidence is needed to analyze the possible effect of vitamin D in reducing CF pulmonary exacerbations.
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spelling doaj.art-22dfe323c1bb42eaa1fac7c4d60ddb782024-03-14T06:16:55ZengElsevierClinical Nutrition Open Science2667-26852024-04-0154163173Effect of vitamin D supplementation on cystic fibrosis pulmonary exacerbations: A pilot randomized crossover clinical trialRenata Ongaratto0Frederico Orlando Friedrich1Gabriele Carra Forte2Gabriela de Azevedo Bastian de Souza3Sofia Prates da Cunha de Azevedo4Laura Gomes Boabaid de Barros5Leonardo Araujo Pinto6Programa de Pós-graduação em Pediatria e Saúde da Criança, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, RS, Brazil; Corresponding author. Centro Clínico da PUCRS, School of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Avenida Ipiranga 6690, cj 715, Porto Alegre, 90610-000, RS, Brazil.Programa de Pós-graduação em Pediatria e Saúde da Criança, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, RS, BrazilSchool of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), BrazilSchool of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), BrazilSchool of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), BrazilSchool of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), BrazilPrograma de Pós-graduação em Pediatria e Saúde da Criança, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, RS, BrazilSummary: Background & Aims: Control of pulmonary exacerbations (PEs) is highly important in the treatment of cystic fibrosis (CF). Given the evidence of the extra skeletal properties of vitamin D, this study aimed to evaluate the effect of supplementation with an extra dose of vitamin D on CF PEs. Methods: This is a randomized crossover clinical trial conducted in Brazil. Subjects were randomly allocated to receive vitamin D (5,000-10,000 IU/day, liquid, or gelatin capsules) followed by standard treatment (400-2,000 IU/day of vitamin D), or standard treatment followed by vitamin D for three months, with 9-month washout separating each treatment period. The primary endpoint was the number of PEs during the intervention period. In addition, a 6-month period following the use of the extra dose and the regular dose were assessed. Secondary outcome included change in serum 25(OH)D after the end of supplementation. Results: 34 subjects completed the study (16 received vitamin D first, and 18 received standard treatment first; median age: 5.16 years (1.74:8.07)). A significant statistical reduction in pulmonary exacerbations with the use of the extra dose of vitamin D was not detected (P = 0.10). No effect of vitamin D on PEs was observed after the end of supplementation. More than half of the subjects had suboptimal levels of 25(OH)D pre-supplementation and only 58% achieved desirable levels of the vitamin. Conclusion: Our findings reinforce the high prevalence of hypovitaminosis D in subjects with CF, despite routine supplementation. Further robust evidence is needed to analyze the possible effect of vitamin D in reducing CF pulmonary exacerbations.http://www.sciencedirect.com/science/article/pii/S2667268524000123Cystic fibrosisVitamin DDietary supplementsPulmonary diseasePediatrics
spellingShingle Renata Ongaratto
Frederico Orlando Friedrich
Gabriele Carra Forte
Gabriela de Azevedo Bastian de Souza
Sofia Prates da Cunha de Azevedo
Laura Gomes Boabaid de Barros
Leonardo Araujo Pinto
Effect of vitamin D supplementation on cystic fibrosis pulmonary exacerbations: A pilot randomized crossover clinical trial
Clinical Nutrition Open Science
Cystic fibrosis
Vitamin D
Dietary supplements
Pulmonary disease
Pediatrics
title Effect of vitamin D supplementation on cystic fibrosis pulmonary exacerbations: A pilot randomized crossover clinical trial
title_full Effect of vitamin D supplementation on cystic fibrosis pulmonary exacerbations: A pilot randomized crossover clinical trial
title_fullStr Effect of vitamin D supplementation on cystic fibrosis pulmonary exacerbations: A pilot randomized crossover clinical trial
title_full_unstemmed Effect of vitamin D supplementation on cystic fibrosis pulmonary exacerbations: A pilot randomized crossover clinical trial
title_short Effect of vitamin D supplementation on cystic fibrosis pulmonary exacerbations: A pilot randomized crossover clinical trial
title_sort effect of vitamin d supplementation on cystic fibrosis pulmonary exacerbations a pilot randomized crossover clinical trial
topic Cystic fibrosis
Vitamin D
Dietary supplements
Pulmonary disease
Pediatrics
url http://www.sciencedirect.com/science/article/pii/S2667268524000123
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