Glycine and magnesium plus thiamine for 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
This trial will test whether daily oral glycine and magnesium with thiamine, alone or combined, can help people aged 5 and older with primary ciliary dyskinesia clear mucus and breathe better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Enfermedades Respiratorias Government |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT06959251 on ClinicalTrials.gov |
What this trial studies
People with confirmed primary ciliary dyskinesia (PCD) who are at least 5 years old will continue their usual care and be assigned to receive oral glycine, magnesium plus thiamine, the combination, or placebo for six months. The study will track lung function, respiratory symptoms, frequency of respiratory exacerbations, and safety/tolerability during the treatment period. Participants must be clinically stable with no respiratory exacerbation or acute infection in the prior 30 days and will attend the Mexico City site for scheduled visits and testing. The supplements are inexpensive, taken orally, and intended as adjuncts to standard airway clearance measures.
Who should consider this trial
Good fit: Ideal candidates are people aged 5 years or older with a confirmed diagnosis of primary ciliary dyskinesia who are clinically stable and have had no recent respiratory exacerbation or acute infection.
Not a fit: Patients enrolled in other therapeutic trials, those with a recent respiratory exacerbation or acute infection, or individuals with advanced irreversible lung damage may be less likely to benefit.
Why it matters
Potential benefit: If successful, these low-cost oral supplements could reduce mucus buildup, improve lung function and symptoms, and lower the rate of respiratory infections in people with PCD.
How similar studies have performed: Glycine has shown benefits for airway clearance in cystic fibrosis and azithromycin reduced exacerbations in PCD, but glycine and magnesium+thiamine have not been widely tested specifically in PCD.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Any sex. 2. Age of 5 years or more. 3. 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). 4. Without respiratory exacerbations of PCD in the previous 30 days. 5. Without acute respiratory infection in the previous 30 days. 6. Informed consent letter signed by the patient (if the patient's age is 18 years or more). 7. Informed consent letter signed by the legal guardian, and assent letter signed by the patient (if the patient's age is \<18 years). Exclusion Criteria: 1\. Participation in other research protocol involving therapeutic measures. Elimination Criteria: 1\. None.
Where this trial is running
Mexico City
- Instituto Nacional de Enfermedades Respiratorias — Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Mario H. Vargas, MSc — 5556665868
- Study coordinator: Mario H. Vargas, MSc
- Email: mhvargasb@yahoo.com.mx
- Phone: 5556665868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.