Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113477
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2005-06-08
Brief Title:
The Effect of Q10 and Selen Supplement on Muscular Adverse Events in Statin Therapy
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
A Single-Centre Randomised Double-Blind Placebo-Controlled Study to Measure the Effect of Q10 and Selen Supplement on Muscular Adverse Events in Statin Therapy
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether supplements of Q10 and Selen are effective in reducing muscular adverse events AE in statin therapy
Detailed Description:
Statins inhibit the synthesis of cholesterol by inhibiting the enzyme HMG-CoA reductase The reduction of intracellular cholesterol leads to an increase in the number of LDL-receptors and subsequent increased uptake and metabolism of LDL in the liver Several large clinical trials have shown that the use of statins decreases morbidity and mortality in patients with risk factors for atherosclerotic disease Unfortunately 5 of statin users experience adverse events mainly gastrointestinal GI and muscular
Statins inhibit not only cholesterol synthesis but also synthesis of other substances in the mevalonate pathway Among these other substances are Q10 and selenoproteins
It is well known that serum Q10 levels decrease during statin therapy and that Q10 supplement inhibits this decrease One study has shown reduction of Q10 in blood-platelets during statin therapy Q10 is an important element in the mitochondrial respiratory chain Depletion of Q10 leads to a reduction of high energy phosphates anaerobe metabolism and mitochondrial dysfunction This is suggested to be the cause of muscular adverse events in statin therapy There are several reports of individuals relieved from muscular adverse effects after Q10 supplement but no randomized placebo controlled studies have been conducted
Symptoms of selenoprotein deficiency are very similar to adverse events seen in statin therapy but no clinical trials have been conducted to evaluate the effect of selen supplement on adverse effects of statin therapy
Statins inhibit not only cholesterol synthesis but also synthesis of other substances in the mevalonate pathway Among these other substances are Q10 and selenoproteins
It is well known that serum Q10 levels decrease during statin therapy and that Q10 supplement inhibits this decrease One study has shown reduction of Q10 in blood-platelets during statin therapy Q10 is an important element in the mitochondrial respiratory chain Depletion of Q10 leads to a reduction of high energy phosphates anaerobe metabolism and mitochondrial dysfunction This is suggested to be the cause of muscular adverse events in statin therapy There are several reports of individuals relieved from muscular adverse effects after Q10 supplement but no randomized placebo controlled studies have been conducted
Symptoms of selenoprotein deficiency are very similar to adverse events seen in statin therapy but no clinical trials have been conducted to evaluate the effect of selen supplement on adverse effects of statin therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 200500691 SLV | None | None | None |
| 2004-000797-31 EudraCT | None | None | None |
| S-04159 REK Sør | None | None | None |
| 11250 NSD | None | None | None |