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

U

Uppsala University Hospital

Status

Unknown

Conditions

IGA Nephropathy

Treatments

Dietary Supplement: Tailored diet
Dietary Supplement: Low antigen content diet

Study type

Interventional

Funder types

Other

Identifiers

NCT01203007
SMR-2259

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Tailored diet
Experimental group
Description:
Tailored diet according to demonstrated food sensitivity
Treatment:
Dietary Supplement: Tailored diet
Low-antigen content (LAC) diet
Experimental group
Description:
Low-antigen content diet
Treatment:
Dietary Supplement: Low antigen content diet

Trial contacts and locations

3

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Central trial contact

Hilde K Smerud, MScPharm; Bengt Fellström, MD, PhD

Data sourced from clinicaltrials.gov

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