Actively Recruiting
Glycine and Magnesium+Thiamine for the Treatment of Primary Ciliary Dyskinesia
Led by Instituto Nacional de Enfermedades Respiratorias · Updated on 2025-11-25
60
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
* Patients with primary ciliary dyskinesia (PCD) have trouble with clearing their bronchi from mucus, which in the long-term may produce severe damage to the lungs. Currently, there is no specific treatment for PCD beyond supportive measures such as airway hydration and postural drainage. * Glycine is an amino acid with anti-inflammatory properties that proved to be beneficial in another disease with problematic airway clearance, cystic fibrosis. * Magnesium participates in many crucial chemical reactions, including some that might favor fluidification and mobilization of mucus. Thiamine (vitamin B1) co-participates with magnesium in some mitochondrial enzymatic reactions occurring in the citric acid cycle. * Thus, oral supplements of glycine and magnesium+thiamine might improve symptoms and lung function of patients with PCD, and these effects may even be better if these supplements are combined. * In this study, in addition to their usual care, patients with PCD will receive for 6 months one of the following treatments: 1) an oral supplement of 0.5 g/kg/day glycine, 2) an oral supplement of up to 400 mg/day elementary magnesium plus up to 10 mg/day thiamine, according to the subject's age, 3) glycine plus magnesium+thiamine supplements, as described, or 4) a placebo, which is an inert substance. All treatments will be administered as a whitish powder contained in similar bottles. * The investigators will evaluate whether glycine and/or magnesium+thiamine reduce exacerbations of the disease, improve pulmonary function and quality of life, and reduce some pro-inflammatory compounds measured in saliva.
CONDITIONS
Official Title
Glycine and Magnesium+Thiamine for the Treatment of Primary Ciliary Dyskinesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any sex
- Age of 5 years or more
- Diagnosis of primary ciliary dyskinesia (PCD) based on international guidelines
- No respiratory exacerbations of PCD in the previous 30 days
- No acute respiratory infection in the previous 30 days
- Signed informed consent by patient if 18 years or older
- Signed informed consent by legal guardian and assent by patient if under 18 years
You will not qualify if you...
- Participation in another research study involving therapeutic treatments
AI-Screening
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Trial Site Locations
Total: 1 location
1
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico, 14080
Actively Recruiting
Research Team
M
Mario H. Vargas, MSc
CONTACT
M
Mario A. Flores-Valadez, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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