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

May 9, 2019 updated by: Gabriella Nurahmani Putri, Indonesia University

Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and National Institute of Health Stroke Scale Score of Acute Ischemic Stroke Patients: A Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 10340
        • Department of Nutrition University of Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Astaxanthin
Astaxanthin supplementation will be given at 2 x 8mg for 7 days.
Drug: Astaxanthine
Other Names:
  • Astaxanthine 8mg
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
Other Names:
  • Astaxanthine placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7 days
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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Study Chair: Salim Harris, SpS, IDI
  • Study Chair: Sri Sukmaniah, SpGK, IDI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2010

Primary Completion (Actual)

June 9, 2010

Study Completion (Actual)

June 9, 2010

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Actual)

May 13, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neuronutrition

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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