Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum vitD Levels in Pediatric Patients With CF
- Conditions
- Cystic Fibrosis Pulmonary ExacerbationVitamin D DeficiencyBone Density, LowCystic Fibrosis in ChildrenCystic FibrosisInflammation Chronic
- Interventions
- Registration Number
- NCT05276960
- Lead Sponsor
- Hospital Infantil de Mexico Federico Gomez
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Cystic Fibrosis
- Another chronic disease (HIV, cancer, renal failure)
- 25-OH-VitD levels < 10 ng/ml or > 30 ng/ml
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Regular supplementation Cholecalciferol Pill 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. Enhanced Supplementation Cholecalciferol Pill 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.
- Primary Outcome Measures
Name Time Method Change in VitD Levels Baseline, every 2 months through study completition, an avarage of 1 year. Serum vitamin D levels up to 30 ng/ml
- Secondary Outcome Measures
Name Time Method Changes in the Bone mineral density 12 months changes in bone mineral content at baseline and at the end of the study
Changes in the number of Pulmonary exacerbations 12 months Number of exacerbations present during 1 year prior and 1 year after the baseline
Trial Locations
- Locations (1)
Hospital Infantil de México Federico Gómez
🇲🇽Mexico City, Mexico