Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
30 participants
INTERVENTIONAL
2023-01-01
2024-02-01
Brief Summary
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Detailed Description
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Alpha lipoic acid (ALA), or thioctacid, is an antioxidant compound which serve as a cofactor for mitochondrial respiratory enzymes. ALA can scavenge free radicals, activate antioxidant systems, and also affect inflammatory markers. It also has unique characteristic. ALA can play as a reduction for oxidized forms of components with antioxidant properties and neutralize reactive oxygen species. Thus, it called as antioxidant of antioxidants
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Interventional arm
including pediatric patients with diabetic nephropathy receiving oral alpha-lipoic acid daily.
The capsule of ALA ( Thiotex 300 mg capsule) contains 300 mg of thioctic acid, manufactured bt Marcyrl Pharmaceutical Industries - Egypt.) The patient will receive 1 capsule twice daily for 3 months. Patients' compliance to therapy will be checked by counting pills.
oral angiotensin-converting enzyme inhibitors (ACE-Is) captopril 25 mg tablet provided their blood pressure will be maintained within normal range for age
Thioctic Acid 333 MG Oral Capsule
Antioxidant compound which serve as a cofactor for mitochondrial respiratory enzymes
Captopril 25Mg Tab
Oral angiotensin-converting enzyme inhibitors
Control Arm
including pediatric patients with diabetic nephropathy receiving placebo that is similar in appearance to the oral alpha-lipoic acid (Thiotex 300 mg capsule) and oral angiotensin-converting enzyme inhibitors (ACE-Is)(Captopril 25 mg tablet) provided their blood pressure will be maintained within normal range for age
Captopril 25Mg Tab
Oral angiotensin-converting enzyme inhibitors
Interventions
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Thioctic Acid 333 MG Oral Capsule
Antioxidant compound which serve as a cofactor for mitochondrial respiratory enzymes
Captopril 25Mg Tab
Oral angiotensin-converting enzyme inhibitors
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The presence of diabetic nephropathy
Exclusion Criteria
* Other diabetic complications than nephropathy
* Elevated liver enzymes
* Hypersensitivity to lipoic acid
* Participation in a previous investigational drug study within the 30 days preceding screening
6 Years
18 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Principal Investigators
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Yasmine I Elhenawy
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University
Locations
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Pediatrics and Adolescents Diabetes Unit (PADU), Pediatrics Hospital, Faculty of Medicine, Ain Shams University
Cairo, , Egypt
Countries
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Central Contacts
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Shymaa El-Morsy
Role: CONTACT
Facility Contacts
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Yasmine Ehenawyl
Role: primary
Other Identifiers
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FMASU MS 662/2022
Identifier Type: -
Identifier Source: org_study_id
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