- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004788
Study of Nutritional Factors in Porphyria
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- Acute intermittent porphyria
- Variegate porphyria and hereditary coproporphyria eligible but analyzed separately
Study Plan
How is the study designed?
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/11886
- UTMB-328
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Clinical Trials on Porphyria
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University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University... and other collaboratorsCompletedAcute Intermittent Porphyria (AIP) | Hereditary Coproporphyria (HCP) | Variegate Porphyria (VP)United States
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The University of Texas Medical Branch, GalvestonTerminatedHereditary Coproporphyria | Acute Intermittent Porphyria | Variegate PorphyriaUnited States
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Alnylam PharmaceuticalsTerminatedAcute Hepatic Porphyria | Acute Intermittent Porphyria (AIP) | Hereditary Coproporphyria (HCP) | Variegate Porphyria (VP) | ALA Dehydratase Deficient Porphyria (ADP) | Hepatic Porphyrias | Porphyria AcuteUnited States
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Alnylam PharmaceuticalsCompletedAcute Hepatic Porphyria | Acute Intermittent Porphyria | Porphyria, Acute Intermittent | Acute Porphyria | Hereditary Coproporphyria (HCP) | Variegate Porphyria (VP) | ALA Dehydratase Deficient Porphyria (ADP)United States, Spain, United Kingdom, Korea, Republic of, Australia, Bulgaria, Canada, Denmark, Finland, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, Sweden, Taiwan
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Alnylam PharmaceuticalsCompletedPorphyria, Acute Intermittent | Acute Intermittent Porphyria (AIP) | Acute Hepatic Porphyria (AHP) | Acute PorphyriaSweden
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The University of Texas Medical Branch, GalvestonActive, not recruitingHereditary Coproporphyria | Acute Intermittent Porphyria | Variegate PorphyriaUnited States
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University of Texas Southwestern Medical CenterNovartis PharmaceuticalsCompletedPorphyria Cutanea TardaUnited States
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Icahn School of Medicine at Mount SinaiRecruitingAcute Intermittent Porphyria (AIP)United States
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Alnylam PharmaceuticalsCompletedAcute Intermittent PorphyriaUnited States, United Kingdom, Sweden
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Zymenex A/SCompleted