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The effect of dietary supplements of alpha lipoic acid and vitamin E on stress oxidative in children with Down syndrome

Comparison of efficacy of vitamin E and alpha lipoic acid in decrease of oxidative stress in children with Down syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013102215111N1
Enrollment
105
Registered
2013-10-30
Start date
2006-01-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down syndrome. Down syndrome

Interventions

Intervention 1: In group 1 a capsule contained 400 IU alpha tocopherol will give to the children every day after dinner or lunch meal for 4 months. Intervention 2: In group 2 a capsule contained 100
Treatment - Other
Treatment - Drugs
In group 1 a capsule contained 400 IU alpha tocopherol will give to the children every day after dinner or lunch meal for 4 months.
In group 2 a capsule contained 100 mg alpha lipoic acidl will give to the children every day after dinner or lunch meal for 4 months.
In group 3 a capsule contained only vegetable oil as a placebotocopherol will give to the children every day after dinner or lunch meal for 4 months.

Sponsors

Exceptional Children Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:confirmation of regular trisomy 21 in children by cytogenetic analysis; not on any medication or vitamin supplementation therapy for six months before the start of intervention.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
MDA. Timepoint: before intervention and after 4 months. Method of measurement: The determination of MDA levels will performed by method of Satho . In this method the reaction of MDA with Thiobarbituric acid (TBA) creates a complex which is determined spectrophotometrically.;Urinary 8-hydroxydeoxyguanosine (8OHdG). Timepoint: before intervention and after 4 months. Method of measurement: 8OHdG in urine samples will assessed using an enzyme-linked immunosorbent assay (ELISA) kit (8OHdG Quantitation, Cell Biolabs, Inc. San Diego ).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Seyyed Mostafa Nachvak

Exceptiona Children Research

smnachvak@hotmail.com+98 21 8880 4568

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026