Overview

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

Status:
Recruiting

Trial end date:
2023-09-30

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hospital Infantil de Mexico Federico Gomez

Treatments:

Cholecalciferol

Criteria

Inclusion Criteria:

- Cystic Fibrosis

Exclusion Criteria:

- Another chronic disease (HIV, cancer, renal failure)

- 25-OH-VitD levels < 10 ng/ml or > 30 ng/ml