Glycine and Magnesium+Thiamine for the Treatment of Primary Ciliary Dyskinesia
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Primary Ciliary Dyskinesia
In brief
* 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.
Key facts
- Study ID
- NCT06959251
- Run by
- Instituto Nacional de Enfermedades Respiratorias
- People needed
- 60
- Starts
- 2025-10-02
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2025-11-25
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Any sex.
- Age of 5 years or more.
- Diagnosis of primary ciliary dyskinesia (PCD) established according to international recommendations (Shapiro et al. Am J Respir Crit Care Med 2018;197(12):e24-e39, and Shapiro et al. Ped Pulmonol 2016;51:115-132).
- Without respiratory exacerbations of PCD in the previous 30 days.
- Without acute respiratory infection in the previous 30 days.
- Informed consent letter signed by the patient (if the patient's age is 18 years or more).
- Informed consent letter signed by the legal guardian, and assent letter signed by the patient (if the patient's age is <18 years).
You may not qualify if…
- Participation in other research protocol involving therapeutic measures.
- Elimination Criteria:
- None.
Where it is running
- Instituto Nacional de Enfermedades Respiratorias — Mexico City, Mexico (enrolling)
Full record on ClinicalTrials.gov
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