Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Double-Blind Placebo-Controlled Trial of Oral Anti-Oxidant Supplementation for the Prevention of Acute Mountain Sickness.
Brief Summary: Acute mountain sickness (AMS), high altitude pulmonary edema (HAPE), and high altitude cerebral edema (HACE) are complications of rapid ascent to high altitude. Several features suggest that raised intracranial pressure (ICP) may be an important factor in the pathogenesis of AMS. Magnetic resonance imaging of HACE patients has demonstrated that the oedema in HACE is of the vasogenic, rather that cytotoxic, type. Thus it is likely that cerebrovascular permeability has an important role in the development of AMS and HACE.

Reactive oxygen species (ROS) have been shown to alter the permeability of the blood-brain barrier in severe ischaemia, causing vasogenic cerebral oedema. Endogenous antioxidant systems may have some capacity to respond to oxidative stress in hypoxia. The plasma concentration of urate, a powerful endogenous antioxidant, rises on acute exposure to high altitude and may play a crucial antioxidant role in systemic hypoxia. This antioxidant prevents free-radical induced cerebral oedema in animal models.

There are numerous sources of ROS in hypoxia, including the mitochondrial electron transfer chain, haemoglobin (Hb) autoxidation and xanthine oxidase activity. There have been several reports of raised markers of oxidative stress in humans at moderate altitude (\<3000m).

Oral antioxidant supplementation with preparations containing vitamins C and E in humans at altitude has been shown to decrease breath pentanes (a marker of oxidative stress), and improve erythrocyte filterability. In a small randomised controlled trial, Bailey and Davies demonstrated a significant reduction in symptoms of AMS in subjects taking an oral antioxidant cocktail.

The antioxidants alpha-lipoic acid, vitamin C and vitamin E act synergistically to provide membrane protection from free radical damage, and may protect against hypoxia-induced vascular leakage. We hypothesised that this combination of antioxidants would reduce the severity of acute mountain sickness, and reduce pulmonary artery pressures, in healthy lowlanders acutely exposed to high altitude.


Options:
A: Arm Label: AREDS participants; Type: N/A; Interventions: N/A
B: Intervention Type: BEHAVIORAL; Name: dietary supplements; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: vitamin C; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: vitamin E; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: beta-carotene; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: folic acid/Vitamin B6/Vitamin B12; Assigned to Arm(s): N/A
C: Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Matched placebo for anti-oxidant supplementation | Arm Label: Intervention; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Anti-oxidant supplementation | Intervention Type: DIETARY_SUPPLEMENT; Name: Anti-oxidant supplementation; Assigned to Arm(s): Intervention | Intervention Type: DIETARY_SUPPLEMENT; Name: Matched placebo for anti-oxidant supplementation; Assigned to Arm(s): Control
D: Intervention Type: DRUG; Name: Natural source Vitamin E 400IU/day; Assigned to Arm(s): N/A

Answer: C