Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00004788 |
| Other study ID # |
199/11886 |
| Secondary ID |
UTMB-328 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
February 24, 2000 |
| Last updated |
June 23, 2005 |
| Start date |
May 1988 |
Study information
| Verified date |
December 2001 |
| Source |
Office of Rare Diseases (ORD) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial 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.
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.
