Oral Glutathione oral powder at 65mg/kg/day

Oral Glutathione oral powder at 65mg/kg/day
Oral Glutathione: Oral Glutathione oral powder

Oral Glutathione

Placebo oral powder at 65mg/kg/day
Placebo: Placebo oral powder

Placebo

Total

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Other refers to participants with either two known, non-F508 del CF mutations, or one known, non-F508 del CF mutation and one unidentified allele which has not been classified as a CF mutation. Unidentified refers to participants with 2 alleles that have not been classified as CF mutations.

Cystic Fibrosis (CF) Genotype

Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

Weight (Z-score)

Weight-for-age Z-score Distribution

Either historical fecal elastase or collected as part of the study.

Fecal Elastase

Difference between the oral glutathione and placebo groups in the 24-week change from baseline in weight-for-age Z-score. Weight-for-age Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

Change in Weight-for-age Z-score

Difference between the oral glutathione and placebo groups in the 24-week change from baseline in height-for-age Z-score. Height-for-age Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

Change in Height-for-age Z-score

Difference between the oral glutathione and placebo groups in the 24-week change from baseline in BMI-for-age Z-score. BMI-for-age Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

Change in BMI-for-age Z-score

Difference between the oral glutathione and placebo groups in the 24-week change from baseline in fecal calprotectin.

Change in Fecal Calprotectin

Difference between the oral glutathione and placebo groups in the 24-week change from baseline in hs-CRP.

Change in High-sensitivity C-reactive Protein (Hs-CRP)

The number and percentage of participants with at least one event over the 24 week follow-up period.

Adverse Events (AEs) and Serious Adverse Events (SAEs)

Rate is defined as the number of events per participant follow-up month.

Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Overall Study

Arthur Baines

Cystic Fibrosis

Childrens Hospital Colorado

Connecticut Childrens Medical Center

Nemours Childrens Clinic

Nemours Children's Clinic

Emory University Hospital

Riley Children's Hospital

Childrens Hospital of Michigan

Helen DeVos Women and Childrens Center

University of Minnesota Medical Center

The Childrens Mercy Hospital

Women and Childrens Hospital of Buffalo

Childrens Hospital of New York/Columbia University Medical Center

Oregon Health & Science University

UT Southwestern Medical Center

Baylor College of Medicine

The University of Vermont Inc.

University of Virginia Health System

Childrens Hospital of Milwaukee

The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis

A Multi Center Placebo Controlled Double Blind Randomized Study Evaluating the Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis

l glutathione/i̇ltihab

The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis

Elm tərəfindən dəstəklənən ən tam dərman bitkiləri bazası