NCT00004788

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1988

Completed
11.8 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2001

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Porphyria

Keywords

inborn errors of metabolismporphyriarare disease

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* Acute intermittent porphyria * Variegate porphyria and hereditary coproporphyria eligible but analyzed separately

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

PorphyriasMetabolism, Inborn ErrorsRare Diseases

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karl Elmo Anderson

    University of Texas

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

May 1, 1988

Last Updated

June 24, 2005

Record last verified: 2001-12