RecruitingNot ApplicableNCT06959251

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

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


Sponsor

Instituto Nacional de Enfermedades Respiratorias

Enrollment

60 participants

Start Date

Oct 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 5 Years

Inclusion Criteria7

  • 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).

Exclusion Criteria3

  • \. Participation in other research protocol involving therapeutic measures.
  • Elimination Criteria:
  • \. None.

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Interventions

DIETARY_SUPPLEMENTGlycine

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_SUPPLEMENTMagnesium+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.

OTHERPlacebo

Patients will receive for 6 months placebo (sugar glass), in a similar daily amount as in experimental arms, and divided in three daily intakes.


Locations(1)

Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico

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NCT06959251


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