Erythrocyte Glutamine Level Relation to Pulmonary Hypertension Risk in Beta Thalassemia Major Children
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03133169 |
|
Recruitment Status :
Completed
First Posted : April 28, 2017
Last Update Posted : August 28, 2019
|
Sponsor:
Assiut University
Information provided by (Responsible Party):
Fatma Sami, Assiut University
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 15, 2017 | |||||||||
| First Posted Date | April 28, 2017 | |||||||||
| Last Update Posted Date | August 28, 2019 | |||||||||
| Actual Study Start Date | June 1, 2017 | |||||||||
| Actual Primary Completion Date | August 25, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
|
|||||||||
| Original Primary Outcome Measures |
|
|||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
|
|||||||||
| Original Secondary Outcome Measures |
|
|||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Erythrocyte Glutamine Level Relation to Pulmonary Hypertension Risk in Beta Thalassemia Major Children | |||||||||
| Official Title | Erythrocyte Glutamine Level Relation to Pulmonary Hypertension Risk in Beta Thalassemia Major Children in Assiut University Children Hospital | |||||||||
| Brief Summary | The study will investigate the relation between erythrocyte glutamine/glutamate ratio and pulmonary hypertension risk in Egyptian thalassemic children in Assiut University Children Hospital | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
|||||||||
| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples Without DNA Description: Plasma sample
|
|||||||||
| Sampling Method | Probability Sample | |||||||||
| Study Population | Upper Egypt thalassemic children aged 10-18 years old attending Assiut University Children Hospital. | |||||||||
| Condition |
|
|||||||||
| Intervention |
|
|||||||||
| Study Groups/Cohorts |
|
|||||||||
| Publications * |
|
|||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
80 | |||||||||
| Original Estimated Enrollment |
30 | |||||||||
| Actual Study Completion Date | August 26, 2019 | |||||||||
| Actual Primary Completion Date | August 25, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||
| Sex/Gender |
|
|||||||||
| Ages | 10 Years to 18 Years (Child, Adult) | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Egypt | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT03133169 | |||||||||
| Other Study ID Numbers | GlnThalassemia | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product |
|
|||||||||
| IPD Sharing Statement |
|
|||||||||
| Current Responsible Party | Fatma Sami, Assiut University | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | Assiut University | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
|
|||||||||
| PRS Account | Assiut University | |||||||||
| Verification Date | August 2019 | |||||||||