NCT06959251

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

Recruiting now NA Last updated 20 November 2025

What this trial tests

NA trial testing Glycine in Primary Ciliary Dyskinesia in 60 participants. Currently enrolling.

Timeline

2 October 2025

Primary endpoint
1 March 2028

1 March 2028

Quick facts

Lead sponsor	Instituto Nacional de Enfermedades Respiratorias
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	2 October 2025
Primary completion	1 March 2028
Estimated completion	1 March 2028
Sites	1 location across Mexico

Drugs / interventions tested

• Glycine (GLYCINE) — full drug profile →
• Magnesium+thiamine
• Placebo

Conditions studied

• Primary Ciliary Dyskinesia — all drugs for Primary Ciliary Dyskinesia →

Sponsor

Instituto Nacional de Enfermedades Respiratorias — full company profile →

Who can join

5 and older, any sex, with Primary Ciliary Dyskinesia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of respiratory exacerbations
  Time frame: 6 months
  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.

Sponsor's own description

* 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.