The Effect of SOD Enzyme on Frailty and HRQOL Among Indonesian Pre-frail Elderly: A Double Blind Randomized Controlled Trial
|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
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:
- SOD enzyme can improve frailty status and health related quality of life among Indonesian pre-frail elderly.
- SOD enzyme can increase anti-oxidant serum status among Indonesian pre-frail elderly.
- SOD enzyme can decrease morbidity among Indonesian pre-frail elderly.
- 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|
- Study design: randomized double blind placebo controlled trial.
- 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.
- Study subject: elderly outpatient (aged 60 years old or more) with pre-frail status, who visit the clinic for medical consultation.
- Data sampling: consecutive method.
- Sample size: 150 subjects (75 control group, 75 intervention group).
- 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.
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- Frailty status [ Time Frame: 6 months (24 weeks) ]Measured by FI-40 item questionnaire.
- Health related quality of life [ Time Frame: 6 months (24 weeks) ]Measured by EQ5D questionnaire.
- 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).
- Morbidity [ Time Frame: 6 months (24 weeks) ]Measured by Cumulative Illness Rating Score (CIRS).
- Hospitalization [ Time Frame: 6 months (24 weeks) ]Observed hospitalization event during the study
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753582
|Contact: Siti Setiati, Prof, MD, PhD||8138985588 ext +firstname.lastname@example.org|
|Contact: Purwita Wijaya Laksmi, MD||8161390993 ext +email@example.com|
|Cipto Mangunkusumo National Hospital||Recruiting|
|Jakarta, Indonesia, 10430|
|Contact: Rahmi Istanti, MARS 8151974578 ext +62 firstname.lastname@example.org|
|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|