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

NCT06959251 | Recruiting DMC

• 1 other identifier: C16-24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Primary ciliary dyskinesia; Glycine; Magnesium; Lung function; thiamine; benfotiamine

Outcome Measures

Primary Outcomes (1)

• Number of respiratory exacerbations

  A respiratory exacerbation will be defined as: 1) any increase in respiratory symptoms that motivated the initiation of antibiotic therapy, or 2) a 10% or more decrease in FEV1 with respect to the FEV1 value at recruitment. A blinded pediatric pulmonologist will review all cases to corroborate whether a suspected episode was indeed a respiratory exacerbation.

  6 months

Secondary Outcomes (26)

• Quality of life-Primary ciliary dyskinesia questionnaire (QOL-PCD)

  6 months

• Weight-for-height

  6 months

• Height-for-age

  6 months

• SpO2

  6 months

• Body mass index

  6 months

Study Arms (4)

Glycine

EXPERIMENTAL

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: Glycine

Magnesium+thiamine

EXPERIMENTAL

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.

Dietary Supplement: Magnesium+thiamine

Glycine plus magnesium+thiamine

EXPERIMENTAL

Patients will receive for 6 months oral supplements of glycine and magnesium+thiamine, as described.

Dietary Supplement: Glycine; Dietary Supplement: Magnesium+thiamine

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Glycine DIETARY_SUPPLEMENT

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.

Glycine; Glycine plus magnesium+thiamine

Magnesium+thiamine DIETARY_SUPPLEMENT

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.

Glycine plus magnesium+thiamine; Magnesium+thiamine

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Instituto Nacional de Enfermedades Respiratorias: lead

Study Sites (1)

Instituto Nacional de Enfermedades Respiratorias

Mexico City, 14080, Mexico

RECRUITING

Related Publications (43)

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MeSH Terms

Conditions

Ciliary Motility Disorders

Interventions

Glycine

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Mario H. Vargas, MSc

  5556665868

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario H. Vargas, MSc

CONTACT

5556665868; mhvargasb@yahoo.com.mx

Mario A. Flores-Valadez, MD

CONTACT

5554871700; mario.flores.valadez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: All study arms will receive similar bottles containing a whitish powder with the corresponding treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: Four arms, parallel design, placebo controlled.

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available indefinitely after publication of the results.
• Access Criteria: Reasonable request directed to the principal investigator.

Locations

ME (1)