Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004788
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Study of Nutritional Factors in Porphyria
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
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:
OBJECTIVES I Determine whether differences in dietary habits are associated with disease activity in patients with acute intermittent porphyria
II Determine whether premenstrual porphyria attacks are associated with increased luteal phase energy requirements
III Determine whether energy requirements are higher than intakes in men with unexplained frequent porphyria attacks
IV Assess the nutritional status of women with acute intermittent porphyria using a comprehensive series of laboratory methods including zinc and pyridoxine status
V Determine whether the frequency of disease exacerbations decreases when dietary and nutritional abnormalities are corrected in these patients
VI Evaluate the safety and efficacy of a parenteral nutrition regimen for patients with acute porphyria attacks
II Determine whether premenstrual porphyria attacks are associated with increased luteal phase energy requirements
III Determine whether energy requirements are higher than intakes in men with unexplained frequent porphyria attacks
IV Assess the nutritional status of women with acute intermittent porphyria using a comprehensive series of laboratory methods including zinc and pyridoxine status
V Determine whether the frequency of disease exacerbations decreases when dietary and nutritional abnormalities are corrected in these patients
VI Evaluate the safety and efficacy of a parenteral nutrition regimen for patients with acute porphyria attacks
Detailed Description:
PROTOCOL OUTLINE Women record diet intake for at least 1 cycle 28 days then undergo a comprehensive nutritional assessment at least once during the follicular and luteal phases of the cycle
Men also record diet intake for at least 1 month and undergo indirect calorimetry and other studies
All patients receive a comprehensive analysis of diet and energy metabolism Energy expenditure resting metabolic rates and basal metabolic rates are determined with indirect calorimetry including measurements taken during the follicular and luteal phases of the cycle Other testing includes hormone assays serology for nutritional studies and a urinary metabolite profile Zinc lead and other metals are measured by atomic absorption spectroscopy
The diagnosis of acute intermittent porphyria is confirmed by erythrocyte porphobilinogen deaminase urinary aminolevulinic acid porphobilinogen and porphyrins and total fecal porphyrins
Patients hospitalized for acute attacks of porphyria during the study will receive standard treatment including intravenous hematin and parenteral support
Men also record diet intake for at least 1 month and undergo indirect calorimetry and other studies
All patients receive a comprehensive analysis of diet and energy metabolism Energy expenditure resting metabolic rates and basal metabolic rates are determined with indirect calorimetry including measurements taken during the follicular and luteal phases of the cycle Other testing includes hormone assays serology for nutritional studies and a urinary metabolite profile Zinc lead and other metals are measured by atomic absorption spectroscopy
The diagnosis of acute intermittent porphyria is confirmed by erythrocyte porphobilinogen deaminase urinary aminolevulinic acid porphobilinogen and porphyrins and total fecal porphyrins
Patients hospitalized for acute attacks of porphyria during the study will receive standard treatment including intravenous hematin and parenteral support
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 |
|---|---|---|---|
| UTMB-328 | None | None | None |