Diet Intervention in Food Sensitive Patients With IgA Nephropathy (DIIGA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Uppsala University Hospital.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Uppsala University Hospital
Collaborators:
University Hospital, Linkoeping
Haukeland University Hospital
Smerud Medical Research International AS
Information provided by:
Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01203007
First received: September 15, 2010
Last updated: September 16, 2010
Last verified: September 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
IGA Nephropathy |
Dietary Supplement: Tailored diet Dietary Supplement: Low antigen content diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy |
Resource links provided by NLM:
Further study details as provided by Uppsala University Hospital:
Primary Outcome Measures:
- Proteinuria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Renal function [ Time Frame: 6 months ] [ Designated as safety issue: No ]Glomerular filtration rate (GFR)
- IgA/IgG immune complexes, incl. glycosylation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- IgA/IgG to dietary antigens [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Hematuria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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: NCT01203007
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203007
Contacts
| 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 |
Locations
| 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 | |
Sponsors and Collaborators
Uppsala University Hospital
University Hospital, Linkoeping
Haukeland University Hospital
Smerud Medical Research International AS
Investigators
| Study Director: | Hilde K Smerud, MScPharm | Uppsala University Hospital |
More Information
| Responsible Party: | Bengt Fellström, Uppsala University Hospital |
| ClinicalTrials.gov Identifier: | NCT01203007 History of Changes |
| Other Study ID Numbers: | SMR-2259 |
| Study First Received: | September 15, 2010 |
| Last Updated: | September 16, 2010 |
| Health Authority: | Sweden: Regionala etikprövningsnämnden i Uppsala Norway: Regional etisk komite, Vest |
Additional relevant MeSH terms:
|
Kidney Diseases Glomerulonephritis, IGA Urologic Diseases Glomerulonephritis |
Nephritis Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on September 27, 2016