Back to resultsDiet Intervention in Food Sensitive Patients With IgA Nephropathy (DIIGA)
Primary Purpose
IGA Nephropathy
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tailored diet
Low antigen content diet
Sponsored by
About this trial
This is an interventional treatment trial for IGA Nephropathy
Eligibility Criteria
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
Sites / Locations
- Haukeland University Hospital
- Linköping University Hospital
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Tailored diet
Low-antigen content (LAC) diet
Arm Description
Tailored diet according to demonstrated food sensitivity
Low-antigen content diet
Outcomes
Primary Outcome Measures
Proteinuria
Secondary Outcome Measures
Renal function
Glomerular filtration rate (GFR)
IgA/IgG immune complexes, incl. glycosylation
IgA/IgG to dietary antigens
Hematuria
Full Information
NCT ID
NCT01203007
First Posted
September 15, 2010
Last Updated
September 16, 2010
Sponsor
Uppsala University Hospital
Collaborators
University Hospital, Linkoeping, Haukeland University Hospital, Smerud Medical Research International AS
1. Study Identification
Unique Protocol Identification Number
NCT01203007
Brief Title
Diet Intervention in Food Sensitive Patients With IgA Nephropathy
Acronym
DIIGA
Official Title
A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Uppsala University Hospital
Collaborators
University Hospital, Linkoeping, Haukeland University Hospital, Smerud Medical Research International AS
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IGA Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tailored diet
Arm Type
Experimental
Arm Description
Tailored diet according to demonstrated food sensitivity
Arm Title
Low-antigen content (LAC) diet
Arm Type
Experimental
Arm Description
Low-antigen content diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Tailored diet
Intervention Description
Tailored diet according to demonstrated food sensitivity, 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Low antigen content diet
Intervention Description
Low-antigen content diet for one month
Primary Outcome Measure Information:
Title
Proteinuria
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Renal function
Description
Glomerular filtration rate (GFR)
Time Frame
6 months
Title
IgA/IgG immune complexes, incl. glycosylation
Time Frame
6 months
Title
IgA/IgG to dietary antigens
Time Frame
6 months
Title
Hematuria
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bengt Fellström, MD, PhD
Phone
+46 18 611 4348
Email
bengt.fellstrom@medsci.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Hilde K Smerud, MScPharm
Phone
+47 9011 6812
Email
hilde.smerud@medsci.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilde K Smerud, MScPharm
Organizational Affiliation
Uppsala University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rune Bjørneklett, MD
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Fernström, MD, PhD
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bengt Fellström, MD, PhD
Phone
+46 18 611 4348
Email
bengt.fellstrom@medsci.uu.se
First Name & Middle Initial & Last Name & Degree
Hilde K Smerud, MScPharm
Phone
+479011 6812
Email
hilde.smerud@medsci.uu.se
First Name & Middle Initial & Last Name & Degree
Bengt Fellström, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Diet Intervention in Food Sensitive Patients With IgA Nephropathy
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