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Metabolic SyndromeNCT01316081

A 4-month Intervention of Antioxidant Supplementation in Overweight Children

A study testing Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine in people with Metabolic Syndrome, run by Swiss Federal Institute of Technology at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In obese children, low antioxidant vitamin intake and reduced antioxidant capacity are common. Weight reduction reduces subclinical inflammation in obese subjects, and, similarly, antioxidant vitamins have been shown to reduce the expression of proinflammatory cytokines. Read more about this study

Who is it for?
Ages 10 to 18 years
Conditions the study is for
Metabolic Syndrome
What is being tested?
Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteSwitzerland
Study dates
Mar 2011to Jun 2012
Phase
Interventional
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 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • age between 10 to 18 years old
  • BMI over the 85th percentile for age and sex

Who cannot join

  • history of nephrolithiasis
  • history of bleeding disorder
  • smoking
  • type 2 diabetes
  • NAFLD
  • Asthma

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Swiss Federal Institute of Technology , Laboratory of Human Nutrition

    Zurich, 8092

Other trials in Switzerland

About this study

Official title: A 4-month, Randomized, Placebo-controlled, Double-blind Intervention of Antioxidant Supplementation in Overweight Children Enrolled in an Outpatient Weight-loss Program: Effects on Oxidative and Inflammatory Markers, Hepcidin, Iron Status, and Components of the Metabolic Syndrome

In obese children, low antioxidant vitamin intake and reduced antioxidant capacity are common. Weight reduction reduces subclinical inflammation in obese subjects, and, similarly, antioxidant vitamins have been shown to reduce the expression of proinflammatory cytokines. Moreover, antioxidants reduce oxidative stress which influences endothelial function and might play a crucial role in the pathogenesis of obesity-related disorders. Furthermore, overweight children and adults have a markedly increased risk for iron deficiency. The mechanism linking obesity with iron deficiency is unclear. Growing evidence suggests that the elevated inflammatory status associated with obesity increases circulating hepcidin and this contributes to iron deficiency. Weight reduction has been shown to be associated with reduced inflammation and serum hepcidin concentrations, and an improved functional iron state. Thus, reducing inflammation in obese children may improve iron metabolism and reduce their risk of iron deficiency.

Therefore, positive effects on subclinical inflammation, hepcidin/iron status and metabolic risk factors in obese children during weight loss may be enhanced by supplementation with antioxidants.

Read more

The aim of the present study is to investigate the effect of 4-month antioxidant supplementation on subclinical inflammation, hepcidin, iron status and components of the metabolic syndrome in overweight children undergoing an outpatient weight-loss program.

Our hypotheses are: 1. During an outpatient weight loss program, antioxidant supplementation will reduce oxidative and inflammatory stress associated with obesity to a greater extent than weight loss alone. 2. This will have two effects, compared to weight loss alone: a.It will reduce circulating hepcidin concentrations, and improve iron status. b.It will improve metabolic and cardiovascular risk factors.

Subjects The investigators plan to enroll 50 children who are participants in outpatient weight-loss programs in the German part of Switzerland. Enrollment will be done with the agreement and assistance of the physician supervising the weight-loss program, and the timing of the study measurements will be incorporated within the existing program schedule. It is anticipated that the baseline blood sample for this study will be obtained from the regular baseline venipuncture for the weight-loss study. Criteria for participation include age between 10 to 18 years and a BMI over the 85th percentile for age and sex. Exclusion criteria include major medical illnesses, including gastrointestinal, inflammatory, bleeding and/or endocrine disorders, a history of nephrolithiasis, unusual dietary habits (e.g. vegetarianism), major food allergies or intolerances (lactose, gluten), smoking, and use of chronic medications or vitamin/mineral antioxidant supplements.

Study design The study will be a double-blind, randomized, placebo-controlled intervention trial. Children will be randomly assigned to one of two groups: antioxidant (AO) or placebo (P) supplement. If it is necessary to enroll children from different weight-loss programs, then randomization will be stratified by program. During the 4-month weight loss period, the AO group will consume oral supplements of ascorbic acid (500mg), alpha tocopherol (400 IU), and 50 µg selenium (all from Burgerstein Vitamins, Rapperswil-Jona, Switzerland) each evening with diner, whereas the P group will consume identical-appearing placebo supplements.

Being tested
Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine
Keywords
antioxidant supplementation, childhood obesity, hepcidin, iron status, oxidative stress, inflammation
Medical subject headings
Metabolic Syndrome, Pediatric Obesity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin C Vitamin E Selenvital all from Burgerstein VitamineDietary supplement

    Also called Burgerstein Vitamin C retard 500mg SWISSMEDIC Nr. 44259028, Burgerstein Vitamin E 400 I.E. SWISSMEDIC Nr. 44562014, Burgerstein Selenvital 50µg

    Vitamin C: 500mg Vitamin E: 400 I.U. Selenium: 50mcg

    Placebo Supplements: identical appearing tablets

Study groups in NCT01316081
Study groupRoleWhat they receive
Antioxidant GroupExperimental500mg Vitamin C 400 I.E. Vitamin E 50 mcg Selenium
Receives: Dietary Supplement: Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine
Placebo GroupPlacebo comparatoridentical appearing placebo supplements
Receives: Dietary Supplement: Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. oxidative markers (isoprostanes)

    Measured: blood sample after 4 months

  2. inflammatory parameters

    Measured: blood sample after 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

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 N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01316081
Sponsor's protocol ID
Aox_obesity_SM
Status last verified
Jun 2012
First submitted
15 Mar 2011
Last updated
19 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Murer SB, Aeberli I, Braegger CP, Gittermann M, Hersberger M, Leonard SW, Taylor AW, Traber MG, Zimmermann MB. Antioxidant supplements reduced oxidative stress and stabilized liver function tests but did not reduce inflammation in a randomized controlled trial in obese children and adolescents. J Nutr. 2014 Feb;144(2):193-201. doi: 10.3945/jn.113.185561. Epub 2013 Dec 18.

    PubMed 24353344

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine in people with Metabolic Syndrome, run by Swiss Federal Institute of Technology at 1 site in Switzerland.

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 2 inclusion and 6 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 19 Jun 2012. 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 Switzerland. 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.

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?

oxidative markers (isoprostanes) (time frame: blood sample after 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01316081, which also lists 1 linked publication.

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 19 Jun 2012.

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