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This study represents a follow-up of the previous study "Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects" (NCT02675660). This study will evaluate the applicability of an oral formulation of L-homoarginine to normalize homoarginine blood levels in patients with acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo capsules containing lactose - oral once weekly administration for six month |
|
| homoarginine | Active Comparator | 125 mg L-homoarginine supplement - oral once weekly administration for six month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 125 mg L-homoarginine | Dietary Supplement | capsules for oral supplementation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Homoarginine serum concentration | Normalization of homoarginine serum concentration to levels >2.1 umol/L. | six month |
| Measure | Description | Time Frame |
|---|---|---|
| Intima-media thickness | Intima-media thickness (IMT) measured at both common carotid arteries using an edge detection system. Plaques are defined as protrusion of ≥1.5 mm in common, internal and external carotid artery. | six month |
| National Institute of Health Stroke Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chi-un Choe, MD | Contact | +49407410 | 22389 | cchoe@uke.de |
| Edzard Schwedhelm, PhD | Contact | +49407410 | 54891 | schwedhelm@uke.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg | Recruiting | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27434056 | Background | Atzler D, Schonhoff M, Cordts K, Ortland I, Hoppe J, Hummel FC, Gerloff C, Jaehde U, Jagodzinski A, Boger RH, Choe CU, Schwedhelm E. Oral supplementation with L-homoarginine in young volunteers. Br J Clin Pharmacol. 2016 Dec;82(6):1477-1485. doi: 10.1111/bcp.13068. Epub 2016 Sep 20. |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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randomized double-blind placebo controlled
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| placebo |
| Other |
capsules for oral supplementation |
|
National Institute of Health Stroke Scale (NIHSS) will be assessed by a neurologist. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 (normal) and 4 (maximum impairment). The maximum possible score is 42, with the minimum score being a 0. |
| six month |
| Modified Ranking Scale | Modified Ranking Scale (mRS) is a scale for measuring the degree of disability of a stroke patients. The scale runs from 0 (perfect health) to 6 (death). | six month |