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出境医 / 临床实验 / Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and NIHSS of Stroke Patients

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

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 Intervention/treatment Phase
Cerebral Stroke Malondialdehyde Oxidative Stress Drug: Astaxanthine Drug: Placebo Oral Tablet 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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 23, 2010
Actual Primary Completion Date : June 9, 2010
Actual Study Completion Date : June 9, 2010
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Astaxanthin
Astaxanthin supplementation will be given at 2 x 8mg for 7 days.
 Drug: Astaxanthine
Other Name: 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 Name: Astaxanthine placebo
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
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Ages Eligible for Study:   40 Years 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

Locations
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Indonesia
Department of Nutrition University of Indonesia
Jakarta, Indonesia, 10340
Sponsors and Collaborators
Indonesia University
Investigators
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Study Chair: Salim Harris, SpS IDI
Study Chair: Sri Sukmaniah, SpGK IDI
Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE March 23, 2010
Actual Primary Completion Date June 9, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry [ Time Frame: 7 days ]
    Using thiobarbituric acid molecules
  • National Institute of Health Stroke Scale on Astaxanthine Treated Stroke Patients [ Time Frame: 7 days ]
    Assessed by expert neurologists
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and NIHSS of Stroke Patients
Official Title  ICMJE Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and National Institute of Health Stroke Scale Score of Acute Ischemic Stroke Patients: A Randomized Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Astaxanthin and Placebo
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Cerebral Stroke
  • Malondialdehyde
  • Oxidative Stress
Intervention  ICMJE
  • Drug: Astaxanthine
    Other Name: Astaxanthine 8mg
  • Drug: Placebo Oral Tablet
    Other Name: Astaxanthine placebo
Study Arms  ICMJE
  • Active Comparator: Astaxanthin
    Astaxanthin supplementation will be given at 2 x 8mg for 7 days.
    Intervention: 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
    Intervention: Drug: Placebo Oral Tablet
Publications *
  • Barber PA, Demchuk AM, Hirt L, Buchan AM. Biochemistry of ischemic stroke. Adv Neurol. 2003;92:151-64. Review.
  • Shen H, Kuo CC, Chou J, Delvolve A, Jackson SN, Post J, Woods AS, Hoffer BJ, Wang Y, Harvey BK. Astaxanthin reduces ischemic brain injury in adult rats. FASEB J. 2009 Jun;23(6):1958-68. doi: 10.1096/fj.08-123281. Epub 2009 Feb 13.
  • Palozza P, Krinsky NI. Astaxanthin and canthaxanthin are potent antioxidants in a membrane model. Arch Biochem Biophys. 1992 Sep;297(2):291-5.
  • Hussein G, Nakamura M, Zhao Q, Iguchi T, Goto H, Sankawa U, Watanabe H. Antihypertensive and neuroprotective effects of astaxanthin in experimental animals. Biol Pharm Bull. 2005 Jan;28(1):47-52.
  • Gariballa SE, Sinclair AJ. Assessment and treatment of nutritional status in stroke patients. Postgrad Med J. 1998 Jul;74(873):395-9. Review.
  • Demirkaya S, Topcuoglu MA, Aydin A, Ulas UH, Isimer AI, Vural O. Malondialdehyde, glutathione peroxidase and superoxide dismutase in peripheral blood erythrocytes of patients with acute cerebral ischemia. Eur J Neurol. 2001 Jan;8(1):43-51.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2019) 		24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 9, 2010
Actual Primary Completion Date June 9, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945526
Other Study ID Numbers  ICMJE Neuronutrition
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gabriella Nurahmani Putri, Indonesia University
Study Sponsor  ICMJE Indonesia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Salim Harris, SpS IDI
Study Chair: Sri Sukmaniah, SpGK IDI
PRS Account Indonesia University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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