Actively Recruiting

Phase Not Applicable
Age: 5Years +
All Genders
NCT06959251

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

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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

Age: 5Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Participation in another research study involving therapeutic treatments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico, 14080

Actively Recruiting

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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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