Diet Intervention in Food Sensitive Patients With IgA Nephropathy

IGA Nephropathy Clinical Trial

— DIIGA  

Official title:

A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01203007
• Other study ID #: SMR-2259
• Status: Not yet recruiting
• Phase: N/A
• First received: September 15, 2010
• Last updated: September 16, 2010
• Start date: September 2010
• Est. completion date: March 2012

Study information

• Verified date: September 2010
• Source: Uppsala University Hospital
• Contact: Bengt Fellström, MD, PhD
• Phone: +46 18 611 4348
• Email: bengt.fellstrom[@]medsci.uu.se
• Is FDA regulated: No
• Health authority: Sweden: Regionala etikprövningsnämnden i UppsalaNorway: Regional etisk komite, Vest
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IGA Nephropathy
• Kidney Diseases

Intervention

Dietary Supplement:
• Tailored diet
Tailored diet according to demonstrated food sensitivity, 6 months
• Low antigen content diet
Low-antigen content diet for one month

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Sweden	Linköping University Hospital	Linköping
Sweden	Uppsala University Hospital	Uppsala

Sponsors (4)

Lead Sponsor	Collaborator
Uppsala University Hospital	Haukeland University Hospital, Smerud Medical Research International AS, University Hospital, Linkoeping

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteinuria		6 months	No
Secondary	Renal function	Glomerular filtration rate (GFR)	6 months	No
Secondary	IgA/IgG immune complexes, incl. glycosylation		6 months	No
Secondary	IgA/IgG to dietary antigens		6 months	No
Secondary	Hematuria		6 months	No