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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05276960
Other study ID # HIM-2021-087
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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