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

Cystic Fibrosis Clinical Trial

Official title:

A Randomized, Double-blind Study of the Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum Vitamin D Levels in Pediatric Patients With Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05276960
• Other study ID #: HIM-2021-087
• Status: Recruiting
• Phase: Phase 4
• Start date: February 22, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2022
• Source: Hospital Infantil de Mexico Federico Gomez
• Contact: Magali Reyes, MSc
• Phone: +525518200666
• Email: maghimfg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Randomized double-blind clinical trial in patients aged 5 to 18 years attending the CF Comprehensive Care clinic in Mexico City. The intervention group will receive an intensification of vitamin D supplementation, with increments of 4000 IU depending on serum levels, the control group will receive supplementation according to the treatment guidelines of the Cystic Fibrosis Foundation, and the dose will be doubled depending on serum levels. In both groups vitamin D levels will be measured at 3, 6, 9, and 12 months, spirometry and sputum culture will also be performed to evaluate the pulmonary function, densitometry to evaluate the bone mineral density and body composition, together with anthropometric evaluation and quantitative bone ultrasound at each visit, in the biochemical evaluation, calcium/creatinine ratio and alkaline phosphatase will be taken at each visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• Cystic Fibrosis

Exclusion Criteria:

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

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cholecalciferol Pill
Dose increments according to serum levels determined every 2 months

Locations

Country	Name	City	State
Mexico	Hospital Infantil de México Federico Gómez	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Infantil de Mexico Federico Gomez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VitD Levels	Serum vitamin D levels up to 30 ng/ml	Baseline, every 2 months through study completition, an avarage of 1 year.
Secondary	Changes in the number of Pulmonary exacerbations	Number of exacerbations present during 1 year prior and 1 year after the baseline	12 months
Secondary	Changes in the Bone mineral density	changes in bone mineral content at baseline and at the end of the study	12 months