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Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum vitD Levels in Pediatric Patients With CF

NCT05276960 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-08

No results posted yet for this study

Summary

Cystic fibrosis (CF) is an autosomal recessive disease caused by alterations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene, characterized by multisystemic alterations, mainly in the lung, intestine, sweat, and bile ducts. In addition to pulmonary involvement, the presence of exocrine pancreatic insufficiency also increases the risk of survival, as it is associated with malnutrition and deficiency of fat-soluble vitamins, such as vitamin D.

Vitamin D, in addition to its role in bone health, in the case of CF patients with chronic inflammation, it has been suggested that many of the cytokines that regulate the inflammatory response contain elements that respond to vitamin D, so vitamin D could play an essential role in the regulation of the inflammatory response in CF, which could favor lung function.

However, more than 50% of CF patients present vitamin D insufficiency or deficiency, despite the different schemes suggested for supplementation in different age groups, which suggests that new strategies are needed to normalize vitamin D levels, which will allow us to see its clinical effect on the inflammatory response, by decreasing the number of exacerbations and thus perpetuating or improving lung function, as well as on bone mineral health.

Conditions

  • Vitamin D Deficiency
  • Cystic Fibrosis
  • Bone Density, Low
  • Inflammation Chronic
  • Cystic Fibrosis in Children
  • Cystic Fibrosis Pulmonary Exacerbation

Interventions

DRUG

Cholecalciferol Pill

Dose increments according to serum levels determined every 2 months

Sponsors & Collaborators

  • Hospital Infantil de Mexico Federico Gomez

    lead OTHER

Principal Investigators

  • Magali R Reyes Apodaca, MSc · Hospital Infantil de Mexico Federico Gomez

  • Mara Medeiros, MD, Msc, PhD · Hospital Infantil de Mexico Federico Gomez

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2024-08-30
Completion
2025-01-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05276960 on ClinicalTrials.gov