NCT05276960

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

Completed Phase 4 Last updated 8 April 2025

What this trial tests

Phase 4 trial testing Cholecalciferol Pill in Vitamin D Deficiency in 40 participants. Completed in 30 January 2025.

Timeline

22 June 2022

Primary endpoint
30 August 2024

30 January 2025

Quick facts

Lead sponsor	Hospital Infantil de Mexico Federico Gomez
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	40
Start date	22 June 2022
Primary completion	30 August 2024
Estimated completion	30 January 2025
Sites	1 location across Mexico

Drugs / interventions tested

• Cholecalciferol Pill — full drug profile →

Conditions studied

• Vitamin D Deficiency — all drugs for Vitamin D Deficiency →
• Cystic Fibrosis — all drugs for Cystic Fibrosis →
• Bone Density, Low — all drugs for Bone Density, Low →
• Inflammation Chronic — all drugs for Inflammation Chronic →

Sponsor

Hospital Infantil de Mexico Federico Gomez

Who can join

Adults 5 to 18, any sex, with Vitamin D Deficiency or Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Role of Vitamin D in Rare Diseases-A Clinical Review.
   Ducki C, Wojtkiewicz M, Bartoszewicz M, Fiedor P. · · 2025 · PMID 40149535 · DOI 10.3390/biomedicines13030558