Comprehensive Analysis of Diet, Energy Metabolism and Hormonal Assays in Porphyria Patients
Data Collection
Metabolic Diseases+7
+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities
+ Nutritional and Metabolic Diseases
Summary
Study start date: May 1, 1988
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Acute intermittent porphyria Variegate porphyria and hereditary coproporphyria eligible but analyzed separately