Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Nutritional Factors in Porphyria

This study has been completed.
Sponsor:
Collaborator:
University of Texas
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004788
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
  Purpose

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.


Condition
Porphyria

Study Type: Observational
Study Design: Primary Purpose: Screening

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 30
Study Start Date: May 1988
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Acute intermittent porphyria
  • Variegate porphyria and hereditary coproporphyria eligible but analyzed separately
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004788

Sponsors and Collaborators
University of Texas
Investigators
Study Chair: Karl Elmo Anderson University of Texas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004788     History of Changes
Other Study ID Numbers: 199/11886, UTMB-328
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
inborn errors of metabolism
porphyria
rare disease

Additional relevant MeSH terms:
Porphyria, Erythropoietic
Porphyrias
Genetic Diseases, Inborn
Metabolic Diseases
Metabolism, Inborn Errors
Skin Diseases
Skin Diseases, Genetic
Skin Diseases, Metabolic

ClinicalTrials.gov processed this record on November 25, 2014