A Randomized, Placebo-controlled Clinical Trial Evaluating the Efficacy and Safety of Glycine and Magnesium+Thiamine Supplements, Alone or Combined, Administered for 6 Months to Patients With Primary Ciliary Dyskinesia

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

* 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Mexico
Instituto Nacional de Enfermedades Respiratorias
RECRUITING
Mexico City
Contact Information
Primary
Mario H. Vargas, MSc
mhvargasb@yahoo.com.mx
5556665868
Backup
Mario A. Flores-Valadez, MD
mario.flores.valadez@gmail.com
5554871700
Time Frame
Start Date: 2025-10-02
Estimated Completion Date: 2028-03
Participants
Target number of participants: 60
Treatments
Experimental: Glycine
Patients will receive for 6 months an oral supplement of 0.5 g/kg/day glycine, up to 25 g/day, divided in three daily intakes.
Experimental: Magnesium+thiamine
Patients will receive for 6 months an oral supplement of up to 400 mg/day, according to age, of elementary magnesium (formulated as magnesium citrate) plus up to 10 mg/day of thiamine (formulated as benfotiamine), divided in three daily intakes.
Experimental: Glycine plus magnesium+thiamine
Patients will receive for 6 months oral supplements of glycine and magnesium+thiamine, as described.
Placebo_comparator: Placebo
Patients will receive for 6 months placebo (sugar glass), in a similar daily amount as in experimental arms, and divided in three daily intakes.
Sponsors
Leads: Instituto Nacional de Enfermedades Respiratorias

This content was sourced from clinicaltrials.gov