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Ensayo clínico controlado2019

High-dose Cholecalciferol Supplementation in Adults with Cystic Fibrosis

Janzen KM, Sakon C, Lehman A, Sommer B, Brown C

Pharmacotherapy · 2 citas

Cómo se estudió

Diseño
Ensayo clínico controlado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento

Quién lo pagó

Financiación
Financiación independiente
Universidad u hospital
Indiana University Health

Según 1 financiador declarado.

Publicación

Publicado
2019-07-06 · Pharmacotherapy · vol. 39 · número 9 · págs. 874–880
Editorial
Wiley
Citado
7 citas · más que el 76% de estudios similares · 0.9× el promedio de su campo
Referencias
11 trabajos
Acceso
Lectura gratuita
Áreas de investigación
Cystic Fibrosis Research Advances · Vitamin D Research Studies · Pancreatitis Pathology and Treatment
Palabras clave
Cholecalciferol, Medicine, Vitamin D and neurology, vitamin D deficiency, Cystic fibrosis, Internal medicine, Gastroenterology, Population, Dosing
MeSH
humans, cystic fibrosis, exocrine pancreatic insufficiency, vitamin d deficiency, cholecalciferol, vitamins, prospective studies, dose-response relationship, drug, dietary supplements, adult, female, male, young adult

5 autores

  • Kristin M. Janzen🇺🇸 · autor de correspondenciaIndiana University Health; Indiana University – Purdue University Indianapolis
  • Colleen M. Sakon🇺🇸Indiana University Health; Indiana University – Purdue University Indianapolis
  • Angela Lehman🇺🇸Indiana University Health; Indiana University – Purdue University Indianapolis
  • Bekah Sommer🇺🇸Indiana University Health; Indiana University – Purdue University Indianapolis
  • Cynthia D. Brown🇺🇸Indiana University Health; Indiana University School of Medicine; Indiana University – Purdue University Indianapolis

Resumen

El texto original del estudio, en el idioma en que se publicó.

Introduction

Despite the availability of consensus guidelines for the treatment of vitamin D deficiency, prospective trials are lacking to examine alternative dosing strategies for adult patients with cystic fibrosis (CF) who do not meet therapeutic goals with standard regimens.

Objectives

The primary objective of this study was to determine the efficacy of high-dose cholecalciferol supplementation in increasing serum vitamin D (25-OHD) levels in adult patients with CF.

Methods

Patients were eligible for inclusion if they were 18 years or older, had baseline 25-OHD levels lower than 30 ng/ml, and were diagnosed with CF and pancreatic insufficiency. Patients were given a single dose of cholecalciferol 300,000 or 500,000 IU based on baseline 25-OHD levels. Response was defined by 25-OHD and ionized calcium levels at 3 months. At 6 months, responders received a second dose of the same strength, and nonresponders were given a weekly supplement of cholecalciferol 50,000 IU in addition to cholecalciferol 500,000 IU. A second 25-OHD level was obtained at 9 months.

Results

Of the 46 patients enrolled, 32 patients (70%) completed the study. Baseline levels of 25-OHD significantly increased over time in the per protocol population at 3 and 9 months. A total of 16 patients (50%) were considered nonresponders and required weekly supplementation.

Conclusion

A protocol using high-dose cholecalciferol or high-dose plus weekly cholecalciferol is safe and effective in treating adult patients with CF and pancreatic insufficiency.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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