Synthesis of Glutathione From Low Birth Weight Newborn Babies

Not Applicable

Terminated

• Conditions: Low Birth Weight
• Interventions: Procedure: Blood sample collection

• Registration Number: NCT00607061
• Lead Sponsor: Nantes University Hospital

Brief Summary

The aim of the study is to determine mechanisms leading to glutathione deficiency in low birth weight newborn babies. Compared to full term neonates, depletion in this population may be due to a decreased synthesis rate or to an enhanced utilization or a combination of both mechanisms.The protocol is constituted of two steps. The objective of the first step is to quantify the blood concentration of glutathione in the artery and the vein of umbilical cord in full term newborn babies. Objectives of the second step are to determine if the glutathione synthesis rate, measured in vitro, is lower in erythrocytes collected from umbilical cord blood of low weight newborn babies compared to full term newborn babies. In this case, the next objective will be to determine if the adjunction of an excess of cysteine in vitro can restore the glutathione synthesis rate in these cells.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-05
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-27
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Blood sample collection	Full term newborn babies with gestational age \> 37 weeks of amenorrhea and weight of birth \> tenth percentile.
2	Blood sample collection	Low birth weight newborn babies (gestational age \< 32 weeks of amenorrhea and/or weight of birth \< 1500 g and/or weight of birth \< third percentile for their gestational age.
3	Blood sample collection	Full term newborn babies (gestational age \> 37 weeks of amenorrhea and weight of birth \> tenth percentile).

Primary Outcome Measures

Name	Time	Method
The glutathione concentration in umbilical cord in full term newborn babies, the glutathione concentration in umbilical cord of low birth weight newborn babies and the effect of the adjunction of an excess of cysteine on the glutathione synthesis rate.

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France