Antioxidant Supplementation in Trauma Patients

Boston Medical Center (BMC)

Status and phase: Terminated; Phase 3

Conditions: Multiple Trauma

Treatments: Dietary Supplement: powdered cornstarch placebo; Dietary Supplement: powdered antioxidant

Study type: Interventional

Funder types: Other

Identifiers

NCT00613392

H-25038

Details and patient eligibility

About

Administration of antioxidants to trauma patients will improve measures of oxidant stress in the blood

Enrollment: 18 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult non pregnant non lactating trauma patient

Exclusion criteria

• GCS <6
• Renal dysfunction (cre > 2.5 mg/dl)
• Hepatic dysfunction ( TBili > 3.0 mg/dl)
• Expected survival < 48 hours
• Burns over > 20% body surface area
• Immune-deficiency syndromes
• Steroid use

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Dietary Supplement: powdered antioxidant

2

Placebo Comparator group

Treatment:

Dietary Supplement: powdered cornstarch placebo