Diet Intervention in Food Sensitive Patients With IgA Nephropathy

N/AUnknownNCT01203007

Uppsala University Hospital40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

IGA Nephropathy

Interventions

Tailored dietDIETARY_SUPPLEMENT

Tailored diet according to demonstrated food sensitivity, 6 months

Low antigen content dietDIETARY_SUPPLEMENT

Low-antigen content diet for one month

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Haukeland University Hospital

Bergen, Norway

Linköping University Hospital

Linköping, Sweden

Uppsala University Hospital

Uppsala, Sweden

Outcomes

Primary Outcomes

Proteinuria

Time frame: 6 months

Secondary Outcomes

Renal function

Glomerular filtration rate (GFR)

Time frame: 6 months

IgA/IgG immune complexes, incl. glycosylation

Time frame: 6 months

IgA/IgG to dietary antigens

Time frame: 6 months

Hematuria

Time frame: 6 months

Central Contacts

Bengt Fellström, MD, PhD

CONTACT

+46 18 611 4348 bengt.fellstrom@medsci.uu.se

Hilde K Smerud, MScPharm

CONTACT

+47 9011 6812 hilde.smerud@medsci.uu.se

Data from ClinicalTrials.gov

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