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Trial record 6 of 6731 for:    senior citizens

The Effect of SOD Enzyme on Frailty and HRQOL Among Indonesian Pre-frail Elderly: A Double Blind Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02753582
Recruitment Status : Unknown
Verified May 2016 by Siti Setiati, Indonesia University.
Recruitment status was:  Recruiting
First Posted : April 28, 2016
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
Siti Setiati, Indonesia University

Brief Summary:

The primary objective is to determine the effect of SOD enzyme on frailty and health related quality of life among Indonesian pre-frail elderly.

The secondary objective is to determine the effect of SOD enzyme on anti-oxidant status, morbidity, and hospitalization among Indonesian pre-frail elderly.

The study hypothesis:

  1. SOD enzyme can improve frailty status and health related quality of life among Indonesian pre-frail elderly.
  2. SOD enzyme can increase anti-oxidant serum status among Indonesian pre-frail elderly.
  3. SOD enzyme can decrease morbidity among Indonesian pre-frail elderly.
  4. SOD enzyme can decrease hospitalization events among Indonesian pre-frail elderly.

Condition or disease Intervention/treatment Phase
Pre-frail Elderly Dietary Supplement: SOD+Gliadin Capsule Dietary Supplement: Placebo Phase 4

Detailed Description:
  1. Study design: randomized double blind placebo controlled trial.
  2. Location and time of study: Geriatric Outpatient Clinic and Internal Medicine Outpatient Clinic in Cipto Mangunkusumo National Hospital Jakarta. Study will be conducted on April 2016 to April 2017.
  3. Study subject: elderly outpatient (aged 60 years old or more) with pre-frail status, who visit the clinic for medical consultation.
  4. Data sampling: consecutive method.
  5. Sample size: 150 subjects (75 control group, 75 intervention group).
  6. Data collection: demographic data, frailty status, health related quality of life, anthropometric data, anti-oxidant serum status, hospitalization during intervention, morbidity, nutritional status, food intake, hand grip strength.
  7. Intervention: SOD+Gliadin in capsule with a dose of 250 mg twice a day for 24 weeks will be given to intervention group, while placebo group will be given placebo capsule (amylum).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Superoxide Dismutase (SOD) Enzyme on Frailty and Health Related Quality of Life Among Indonesian Pre-frail Elderly: A Double Blind Randomized Controlled Trial
Study Start Date : April 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : April 2017

Arm Intervention/treatment
Active Comparator: Intervention
SOD+Gliadin capsule is given in a dosage of 250 mg twice a day, for 24 weeks.
Dietary Supplement: SOD+Gliadin Capsule
Other Name: GLISODin

Placebo Comparator: Placebo
Placebo capsule is given in a dosage of 250 mg twice a day, for 24 weeks.
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Frailty status [ Time Frame: 6 months (24 weeks) ]
    Measured by FI-40 item questionnaire.


Secondary Outcome Measures :
  1. Health related quality of life [ Time Frame: 6 months (24 weeks) ]
    Measured by EQ5D questionnaire.

  2. Anti-oxidant serum status [ Time Frame: 6 months (24 weeks) ]
    Measured by erythrocyte antioxidant enzymes activity, i.e. superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX).

  3. Morbidity [ Time Frame: 6 months (24 weeks) ]
    Measured by Cumulative Illness Rating Score (CIRS).

  4. Hospitalization [ Time Frame: 6 months (24 weeks) ]
    Observed hospitalization event during the study



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elderly aged 60 years or more with pre-frail condition
  • Patients with SOD enzyme deficiency
  • Willing to participate

Exclusion Criteria:

  • Patients with cognitive function impairment (AMT score < 8)
  • Patients with depression (Geriatric depression scale score >= 10)
  • Patients with history of cirrhotic hepatic disease or severe hepatic disease
  • Patients with kidney function impairment
  • Patients with gluten allergy and derivative products
  • Patients consume other antioxidant and omega-3 supplement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753582


Contacts
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Contact: Siti Setiati, Prof, MD, PhD 8138985588 ext +62 s_setiati@yahoo.com
Contact: Purwita Wijaya Laksmi, MD 8161390993 ext +62 pwlaksmi@yahoo.com

Locations
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Indonesia
Cipto Mangunkusumo National Hospital Recruiting
Jakarta, Indonesia, 10430
Contact: Rahmi Istanti, MARS    8151974578 ext +62    r_istanti@hotmail.com   
Sponsors and Collaborators
Indonesia University
Investigators
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Study Chair: Siti Setiati, Prof, MD, PhD Fakultas Kedokteran Universitas Indonesia
Study Director: Purwita Wijaya Laksmi, MD Fakultas Kedokteran Universitas Indonesia
Principal Investigator: Kuntjoro Harimurti, MD Fakultas Kedokteran Universitas Indonesia
Principal Investigator: Rahmi Istanti, MARS Fakultas Kedokteran Universitas Indonesia

Publications:

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Responsible Party: Siti Setiati, Prof. MD, PhD, Indonesia University
ClinicalTrials.gov Identifier: NCT02753582     History of Changes
Other Study ID Numbers: SOD
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Siti Setiati, Indonesia University:
Elderly, pre-frail, SOD
Additional relevant MeSH terms:
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Frailty
Pathologic Processes