Diet Intervention in Food Sensitive Patients With IgA Nephropathy (DIIGA)

September 16, 2010 updated by: Uppsala University Hospital

A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy

The purpose of this study is to assess whether a tailored diet, eliminating antigens to which IgA nephropathy patients have demonstrated sensitivity, will have an effect on proteinuria, renal function and other immunological variables.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
      • Bergen, Norway
        • Haukeland University Hospital
        • Principal Investigator:
          • Rune Bjørneklett, MD
  • Sweden
      • Linköping, Sweden
        • Linkoping University Hospital
        • Principal Investigator:
          • Anders Fernström, MD, PhD
      • Uppsala, Sweden
        • Uppsala University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bengt Fellström, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Above 18 years
  • IgA nephropathy (IgAN), verified by biopsy
  • Proteinuria > 1 g/24 h
  • Having signed informed consent form

Exclusion Criteria:

  • Participation in another clinical trial
  • Patients with celiac disease
  • Introduction of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blockers (ARB) during the last three months prior to inclusion
  • Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tailored diet
Tailored diet according to demonstrated food sensitivity
Dietary supplement: Tailored diet
Tailored diet according to demonstrated food sensitivity, 6 months
Experimental: Low-antigen content (LAC) diet
Low-antigen content diet
Dietary supplement: Low antigen content diet
Low-antigen content diet for one month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proteinuria
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal function
Time Frame: 6 months
Glomerular filtration rate (GFR)
6 months
IgA/IgG immune complexes, incl. glycosylation
Time Frame: 6 months
6 months
IgA/IgG to dietary antigens
Time Frame: 6 months
6 months
Hematuria
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Collaborators

Haukeland University Hospital
University Hospital, Linkoeping
Smerud Medical Research International AS

Investigators

  • Study Director: Hilde K Smerud, MScPharm, Uppsala University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

September 17, 2010

Last Update Submitted That Met QC Criteria

September 16, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMR-2259

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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