Obesity, AdolescentPhase 4NCT03358524
Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia
A Phase 4 study testing Vitamin E 400 UNT in people with Obesity, Adolescent and Oxidative Stress, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study evaluate supplementation of vitamin E (alpha-tocopherol) in obese adolescent. Half of the patient will receive vitamin E and the other half received placebo Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent, Oxidative Stress
- What is being tested?
- Vitamin E 400 UNT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Sep 2017to 1 Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Obesity BMI ≥ p95 (CDC growth curve)
Who cannot join
- Consuming antioxidants drug regularly within recruiting time
- Consuming Orlistat
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vitamin E (Alfa-Tocoferol) Supplementation on Isoprostane and Lipid Profile of Obese Adolescent in Jakarta, Indonesia
This study evaluate supplementation of vitamin E (alpha-tocopherol) in obese adolescent. Half of the patient will receive vitamin E and the other half received placebo
Read the detailed description
One of obesity treatments that play important role is antioxidant diet. The effects of vitamin E supplementation as an antioxidant treatment in obese adolescent have not been concluded yet in Indonesia. The primary aim of this study is to observe oxidative stress biomarker (isoprostane) in obese teenagers who consume vitamin E for 2 months. The secondary aim is to observe their body mass index and lipid profile after supplementation
The study is randomized, double blind, placebo controlled trial in design and employed a consecutive sampling technique to sample subjects of 70 obese adolescent age 14 - 18 in senior high schools Jakarta.
Blood tests of lipid profile (total cholesterol, HDL, LDL, Triglyceride), fasting blood glucose, liver function (AST,ALT) and oxidative stress biomarker (isoprostane) were taken for every subject after done fasting for 12 hours.
This study is a randomized allocation and double blind technique. subjects divided into two groups, which one group receiving treatment of vitamin E and other group receiving placebo.
The dose and duration of vitamin E treatment is 400 IU per day for 2 months. At the end of treatment, all subjects had to run the same medical interview, physical examination and blood test.
- Conditions
- Obesity, Adolescent, Oxidative Stress
- Being tested
- Vitamin E 400 UNT, Placebo oral capsule
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin E 400 UNTDrug
Also called Vitamin E
Vitamin-E capsule (alpha tocopherol) 400 IU (once per day)
Placebo oral capsuleDrug
Also called Placebo
sugar capsule manufactured to mimic vitamin E capsule once per day
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E 400 IU | Experimental | Vitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks Receives: Drug: Vitamin E 400 UNT |
| Placebo | Placebo comparator | Placebo capsule once per day orally for 8 weeks Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isoprostane (oxidative stress)
pg/ml
Measured: 8 weeks
Secondary outcomes (7)
Total Cholesterol
mg/dl
Measured: 8 weeks
LDL Cholesterol
mg/dl
Measured: 8 weeks
HDL Cholesterol
mg/dl
Measured: 8 weeks
Triglycerides
mg/dl
Measured: 8 weeks
Body weight
kilograms
Measured: 8 weeks
Body Height
centimeters
Measured: 8 weeks
BMI
kg/m^2
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start28 Sep 2017
- Primary completion20 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Alhadar, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358524
- Sponsor's protocol ID
- 001
- Status last verified
- Mar 2018
- First submitted
- 25 Nov 2017
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin E (Alfa-Tocoferol) Supplementation on Isoprostane and Lipid Profile of Obese Adolescent in Jakarta, Indonesia
- ClinicalTrials.gov ID
- NCT03358524
- Acronym / sponsor ID
- 001
- Conditions
- Obesity, Adolescent, Oxidative Stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluate supplementation of vitamin E (alpha-tocopherol) in obese adolescent. Half of the patient will receive vitamin E and the other half received placebo
Detailed description
One of obesity treatments that play important role is antioxidant diet. The effects of vitamin E supplementation as an antioxidant treatment in obese adolescent have not been concluded yet in Indonesia. The primary aim of this study is to observe oxidative stress biomarker (isoprostane) in obese teenagers who consume vitamin E for 2 months. The secondary aim is to observe their body mass index and lipid profile after supplementation
The study is randomized, double blind, placebo controlled trial in design and employed a consecutive sampling technique to sample subjects of 70 obese adolescent age 14 - 18 in senior high schools Jakarta.
Blood tests of lipid profile (total cholesterol, HDL, LDL, Triglyceride), fasting blood glucose, liver function (AST,ALT) and oxidative stress biomarker (isoprostane) were taken for every subject after done fasting for 12 hours.
This study is a randomized allocation and double blind technique. subjects divided into two groups, which one group receiving treatment of vitamin E and other group receiving placebo.
The dose and duration of vitamin E treatment is 400 IU per day for 2 months. At the end of treatment, all subjects had to run the same medical interview, physical examination and blood test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin E 400 IU | Experimental | Drug: Vitamin E 400 UNTVitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks |
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo capsule once per day orally for 8 weeks |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Obesity BMI ≥ p95 (CDC growth curve)
Key exclusion criteria (2 listed)
- Consuming antioxidants drug regularly within recruiting time
- Consuming Orlistat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin E 400 UNTAlso: Vitamin EVitamin-E capsule (alpha tocopherol) 400 IU (once per day) | Drug | Vitamin E 400 IU |
| Placebo oral capsuleAlso: Placebosugar capsule manufactured to mimic vitamin E capsule once per day | Drug | Placebo |
Primary outcome
Isoprostane (oxidative stress)
Time frame: 8 weeks
pg/ml
7 secondary outcomes
Total Cholesterol
Time frame: 8 weeks
LDL Cholesterol
Time frame: 8 weeks
HDL Cholesterol
Time frame: 8 weeks
Triglycerides
Time frame: 8 weeks
Body weight
Time frame: 8 weeks
Body Height
Time frame: 8 weeks
BMI
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin E 400 UNT in people with Obesity, Adolescent and Oxidative Stress, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isoprostane (oxidative stress) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.