Effect of Glycine in Cystic Fibrosis

NCT01417481 | Terminated Phase 2 Results DMC

• 1 other identifier: Glycine in CF
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this study is to evaluate if glycine, orally administered in a daily dose of 0.5 g/kg during 8 weeks, can ameliorate the airway inflammation in children with cystic fibrosis, as compared with placebo. During all of the study children will receive their usual treatment for cystic fibrosis.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; glycine; airway inflammation

Outcome Measures

Primary Outcomes (5)

• Changes in Serum Concentration of Inflammatory Biomarkers (Other Than TNF-alpha)

  To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value \[beginning of the glycine or placebo period, respectively\]). Then, percentages were log-transformed to adjust to a normal distribution.

  8 weeks

• Changes in Sputum Concentration of Inflammatory Biomarkers (Other Than IL-6 and G-CSF)

  To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value \[beginning of the glycine or placebo period, respectively\]). Then, percentage change was log-transformed to adjust to a normal distribution.

  8 weeks

• Changes in Serum Concentration of Inflammatory Biomarkers (TNF-alpha)

  To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value \[beginning of the glycine or placebo period, respectively\]). Then, percentages were log-transformed to adjust to a normal distribution.

  8 weeks

• Changes in Sputum Concentration of Inflammatory Biomarkers (IL-6)

  To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value \[beginning of the glycine or placebo period, respectively\]). Then, percentage change was log-transformed to adjust to a normal distribution.

  8 weeks

• Changes in Sputum Concentration of Inflammatory Biomarkers (G-CSF)

  To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value \[beginning of the glycine or placebo period, respectively\]). Then, percentage change was log-transformed to adjust to a normal distribution.

  8 weeks

Secondary Outcomes (5)

• Changes in Clinical Data Scores (Other Than Sputum Production, Dyspnea and Global Symptoms)

  8 weeks

• Changes in Score for Sputum Production, Dyspnea and Global Symptoms

  8 weeks

• Changes in Pulse Oximetry, FEV1/FVC, and FEF50.

  8 weeks

• Changes in FEV1, FEF25, and FEFmax

  8 weeks

• Changes in Other Spirometric Variables

  8 weeks

Study Arms (2)

Glycine

ACTIVE COMPARATOR

Patients will receive a daily oral supplement of 0.5 g/kg glycine dissolved in water.

Dietary Supplement: Glycine

Placebo

PLACEBO COMPARATOR

Patients will receive a daily supplement of 0.5 g/kg sugar glass dissolved in water.

Dietary Supplement: Placebo

Interventions

Glycine DIETARY_SUPPLEMENT

Daily oral supplement of glycine at a dose of 0.5 g/kg divided in three doses during 8 weeks

Also known as: aminoacetic acid

Glycine

Placebo DIETARY_SUPPLEMENT

Daily oral administration of placebo (sugar glass) at a dose of 0.5 g/kg divided in three doses during 8 weeks

Also known as: sugar glass

Placebo

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of either sex
• Between 5 and 15 years of age
• With CF diagnosed according to established criteria
• Without changes in the CF treatment in the last 30 days
• Without CF exacerbation in the last 30 days
• Without acute respiratory infection (e.g., common cold) in the last 15 days
• Informed consent letter signed by their parents or legal guardians

You may not qualify if:

• Children with CF that had participated in a research protocol in the last 3 months
• Presence of serious adverse effects attributable to glycine, in which case the result will be considered as therapeutic failure in the statistical analysis
• Development of a CF exacerbation, in which case the available data so far collected will be included in the statistical analysis

Sponsors & Collaborators

• Instituto Nacional de Enfermedades Respiratorias: lead
• Hospital Infantil de Mexico Federico Gomez: collaborator
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (3)

Hospital Infantil de México

Mexico City, 06720, Mexico

Location

Unidad de Investigación Médica en Enfermedades Respiratorias, Hospital de Pediatría, CMN SXXI, IMSS

Mexico City, 06720, Mexico

Location

Instituto Nacional de Enfermedades Respiratorias

Mexico City, 14080, Mexico

Location

Related Publications (5)

• Cohen-Cymberknoh M, Shoseyov D, Kerem E. Managing cystic fibrosis: strategies that increase life expectancy and improve quality of life. Am J Respir Crit Care Med. 2011 Jun 1;183(11):1463-71. doi: 10.1164/rccm.201009-1478CI. Epub 2011 Feb 17.

  PMID: 21330455 BACKGROUND

• Wheeler MD, Ikejema K, Enomoto N, Stacklewitz RF, Seabra V, Zhong Z, Yin M, Schemmer P, Rose ML, Rusyn I, Bradford B, Thurman RG. Glycine: a new anti-inflammatory immunonutrient. Cell Mol Life Sci. 1999 Nov 30;56(9-10):843-56. doi: 10.1007/s000180050030.

  PMID: 11212343 BACKGROUND

• Wheeler MD, Rose ML, Yamashima S, Enomoto N, Seabra V, Madren J, Thurman RG. Dietary glycine blunts lung inflammatory cell influx following acute endotoxin. Am J Physiol Lung Cell Mol Physiol. 2000 Aug;279(2):L390-8. doi: 10.1152/ajplung.2000.279.2.L390.

  PMID: 10926563 BACKGROUND

• Garcia-Macedo R, Sanchez-Munoz F, Almanza-Perez JC, Duran-Reyes G, Alarcon-Aguilar F, Cruz M. Glycine increases mRNA adiponectin and diminishes pro-inflammatory adipokines expression in 3T3-L1 cells. Eur J Pharmacol. 2008 Jun 10;587(1-3):317-21. doi: 10.1016/j.ejphar.2008.03.051. Epub 2008 Apr 8.

  PMID: 18499099 BACKGROUND

• Vargas MH, Del-Razo-Rodriguez R, Lopez-Garcia A, Lezana-Fernandez JL, Chavez J, Furuya MEY, Marin-Santana JC. Effect of oral glycine on the clinical, spirometric and inflammatory status in subjects with cystic fibrosis: a pilot randomized trial. BMC Pulm Med. 2017 Dec 15;17(1):206. doi: 10.1186/s12890-017-0528-x.

  PMID: 29246256 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Glycine

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Mario H. Vargas
• Organization: Instituto Nacional de Enfermedades Respiratorias

mhvargasb@yahoo.com.mx

(+55)54871771

Study Officials

• Mario H Vargas, MD, MSc

  Instituto Nacional de Enfermedades Respiratorias

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 16, 2011
• Study Start: March 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 5, 2014
• Results First Posted: October 23, 2014

Record last verified: 2014-10

Locations

ME (3)