Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004347
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Study of Dietary Cholesterol for Smith-Lemli-Opitz Syndrome
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
The Effects of Dietary Cholesterol in the Smith-Lemli-Opitz Syndrome
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
RECRUITING
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:
OBJECTIVES I Examine the intestinal absorption of dietary cholesterol in patients with Smith-Lemli-Opitz syndrome
II Measure the effect of dietary cholesterol on plasma sterol composition III Quantify basal cholesterol synthesis turnover of cholesterol and 7-dehydrocholesterol and the effects of dietary cholesterol on these parameters
IV Identify fecal bile acid excretion quantitatively and qualitatively in these patients
V Compare the incorporation of deuterated water into plasma cholesterol 7-dehydrocholesterol and other intermediates and assess the effect of dietary cholesterol on this incorporation
II Measure the effect of dietary cholesterol on plasma sterol composition III Quantify basal cholesterol synthesis turnover of cholesterol and 7-dehydrocholesterol and the effects of dietary cholesterol on these parameters
IV Identify fecal bile acid excretion quantitatively and qualitatively in these patients
V Compare the incorporation of deuterated water into plasma cholesterol 7-dehydrocholesterol and other intermediates and assess the effect of dietary cholesterol on this incorporation
Detailed Description:
PROTOCOL OUTLINE
Patients are treated with 2 dietary regimens for 1 to 3 weeks high cholesterol and cholesterol-free Cholesterol is provided in the form of egg yolk The absorption and metabolism of cholesterol are evaluated with plasma and fecal studies Deuterated water is given to patients followed by analysis of deuterium in plasma cholesterol and other intermediates including 7-dehydrocholesterol
Patients are treated with 2 dietary regimens for 1 to 3 weeks high cholesterol and cholesterol-free Cholesterol is provided in the form of egg yolk The absorption and metabolism of cholesterol are evaluated with plasma and fecal studies Deuterated water is given to patients followed by analysis of deuterium in plasma cholesterol and other intermediates including 7-dehydrocholesterol
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OHSU-4019 | None | None | None |