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

NCT ID: NCT05276960

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2025-01-30

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Regular supplementation

Baseline dose of 2000 IU of vitamin D3, based on Cystic Fibrosis Foundation (CFF) treatment guidelines. According to serum vitamin D levels, 2000 IU increments will be performed whenever 25-OH-VitD (25-hydroxy vitamin D) values \< 30 ng/ml are found.

Group Type: ACTIVE_COMPARATOR

Cholecalciferol Pill

Intervention Type: DRUG

Dose increments according to serum levels determined every 2 months

Enhanced Supplementation

Basal dose of 4000 IU of vitamin D3. According to serum vitamin D levels, increments of 4000 IU will be made each time 25-OH-VitD values \< 30 ng/ml are found.

Group Type: EXPERIMENTAL

Cholecalciferol Pill

Intervention Type: DRUG

Dose increments according to serum levels determined every 2 months

Interventions

Cholecalciferol Pill

Dose increments according to serum levels determined every 2 months

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Infantil de Mexico Federico Gomez

OTHER

Sponsor Role: lead

Responsible Party

Magali Reyes Apodaca

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magali R Reyes Apodaca, MSc

Role: PRINCIPAL_INVESTIGATOR

Hospital Infantil de Mexico Federico Gomez

Mara Medeiros, MD, Msc, PhD

Role: STUDY_DIRECTOR

Hospital Infantil de Mexico Federico Gomez

Locations

Hospital Infantil de México Federico Gómez

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

HIM-2021-087

Identifier Type: -

Identifier Source: org_study_id