Diet Intervention in Food Sensitive Patients With IgA Nephropathy (DIIGA)
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ClinicalTrials.gov Identifier: NCT01203007 |
Recruitment Status
: Unknown
Verified September 2010 by Uppsala University Hospital.
Recruitment status was: Not yet recruiting
First Posted
: September 16, 2010
Last Update Posted
: September 17, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
IGA Nephropathy | Dietary Supplement: Tailored diet Dietary Supplement: Low antigen content diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy |
Study Start Date : | September 2010 |
Estimated Primary Completion Date : | January 2012 |
Estimated Study Completion Date : | March 2012 |
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
|
- Proteinuria [ Time Frame: 6 months ]
- Renal function [ Time Frame: 6 months ]Glomerular filtration rate (GFR)
- IgA/IgG immune complexes, incl. glycosylation [ Time Frame: 6 months ]
- IgA/IgG to dietary antigens [ Time Frame: 6 months ]
- Hematuria [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203007
Contact: Bengt Fellström, MD, PhD | +46 18 611 4348 | bengt.fellstrom@medsci.uu.se | |
Contact: Hilde K Smerud, MScPharm | +47 9011 6812 | hilde.smerud@medsci.uu.se |
Norway | |
Haukeland University Hospital | Not yet recruiting |
Bergen, Norway | |
Principal Investigator: Rune Bjørneklett, MD | |
Sweden | |
Linköping University Hospital | Not yet recruiting |
Linköping, Sweden | |
Principal Investigator: Anders Fernström, MD, PhD | |
Uppsala University Hospital | Not yet recruiting |
Uppsala, Sweden | |
Contact: Bengt Fellström, MD, PhD +46 18 611 4348 bengt.fellstrom@medsci.uu.se | |
Contact: Hilde K Smerud, MScPharm +479011 6812 hilde.smerud@medsci.uu.se | |
Principal Investigator: Bengt Fellström, MD, PhD |
Study Director: | Hilde K Smerud, MScPharm | Uppsala University Hospital |
Responsible Party: | Bengt Fellström, Uppsala University Hospital |
ClinicalTrials.gov Identifier: | NCT01203007 History of Changes |
Other Study ID Numbers: |
SMR-2259 |
First Posted: | September 16, 2010 Key Record Dates |
Last Update Posted: | September 17, 2010 |
Last Verified: | September 2010 |
Additional relevant MeSH terms:
Kidney Diseases Glomerulonephritis, IGA Urologic Diseases Glomerulonephritis |
Nephritis Autoimmune Diseases Immune System Diseases |