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Glycine and Magnesium+Thiamine for the Treatment of Primary Ciliary Dyskinesia

NCT06959251 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

  • Primary Ciliary Dyskinesia

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

OTHER

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 & Collaborators

  • Instituto Nacional de Enfermedades Respiratorias

    lead OTHER_GOV

Principal Investigators

  • Mario H. Vargas, MSc · 5556665868

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-02
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06959251 on ClinicalTrials.gov