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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and NIHSS of Stroke Patients

Clinicaltrials.gov identifier NCT03945526

Recruitment Status Completed

First Posted May 10, 2019

Last update posted May 13, 2019

Study Description

Brief summary:

This is an interventional randomized, controlled trial in analyzing the effects of astaxanthin supplementation on plasma malondialdehyde levels and NIHSS of acute ischemic stroke patients. According to published studies, it was hypothesized that acute ischemic stroke patients who were given astaxanthin would have lower plasma malondialdehyde levels and lower NIHSS score compared to the control group.

  • Condition or Disease:Oxidative Stress
    Cerebral Stroke
    Malondialdehyde
  • Intervention/Treatment: Drug: Astaxanthine
    Drug: Placebo Oral Tablet
  • Phase: Phase 1
Detailed Description

There were a total of 24 subjects, with 12 subjects in the intervention group and 12 subjects in the control group.The participants were divided into an interventional group and a control group. The interventional group was given astaxanthin supplementation 2 x 8mg per day for 7 days, while the control group was given placebo.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 24 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Astaxanthin and Placebo
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Official Title: Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and National Institute of Health Stroke Scale Score of Acute Ischemic Stroke Patients: A Randomized Trial
  • Actual Study Start Date: March 2010
  • Actual Primary Completion Date: June 2010
  • Actual Study Completion Date: June 2010
Arms and interventions
Arm Intervention/treatment
Active Comparator: Astaxanthin
Astaxanthin supplementation will be given at 2 x 8mg for 7 days.
Drug: Astaxanthine
Placebo Comparator: Control
A placebo will be given, which takes the form of a drug with the exact same shape and color as astaxanthin supplementation
Drug: Placebo Oral Tablet
Outcome Measures
  • Primary Outcome Measures: 1. Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry [ Time Frame: 7 days ]
    This method used Thiobarbituric acid reaction (TBAR) with substances such as malondialdehyde. The scale was 0.367 nmol/ml-0.707 nmol/ml. The value above 0.707nmol/ml would be the worse outcome, and value less than 0.367nmol/ml would be the best outcome. Bivariate analysis was used to analyze the results (T-test or the Mann-Whitney Test).
  • 2. National Institute of Health Stroke Scale on Astaxanthine Treated Stroke Patients [ Time Frame: 7 days ]
    Score scale was 4-15, where less than 4 indicates mild neurologic deficit, 4-15 moderate neurologic deficit, and more than 15 severe neurologic deficit. They will be assessed before and after the trial to compare how each participant improved after given the intervention.
Eligibility Criteria
  • Ages Eligible for Study: 40 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- 40-65 years old

- Has acute ischemic stroke with an onset of less than 48 hours before hospital
admission

- NIHSS score of less than or equal to 15

- Can consume food orally or enterally

- Has given their consent to be a participant in the study

Exclusion Criteria:

- Renal failure

- Liver failure

- Is taking supplements other than his or her main stroke medications

- Has taken antioxidant supplements in the last 3 months before stroke onset

Contacts and Locations
Contacts
Locations

Indonesia
Department of Nutrition University of Indonesia
Jakarta

Sponsors and Collaborators

Indonesia University

Investigators

Study Chair: Salim Harris, SpS IDI

Study Chair: Sri Sukmaniah, SpGK IDI

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