Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01957423
• Date of registration: 24/09/2013
• Prospective Registration: No
• Primary sponsor: University of Campinas, Brazil
• Public title: Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients.
• Scientific title: Immune Response Regulation and Nutritional Status of Crohn's Disease Patients Under Anti-TNF-alpha and Azathioprine Therapy.
• Date of first enrolment: March 2012
• Target sample size: 41
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01957423
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Maria MS Vilela, MD PhD
• Affiliation: University of Campinas

Key inclusion & exclusion criteria

Inclusion Criteria:

- Crohn's disease patients treated with azathioprine or anti-tumor necrosis
factor-alpha (anti-TNF-alpha) or azathioprine and anti-TNF-alpha

Exclusion Criteria:

- smokers

- who were using other medication or nutritional supplements.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Dietary Supplement: Soy protein

Dietary Supplement: Whey protein

Primary Outcome(s)

Body mass index [Time Frame: 16 weeks]

Secondary Outcome(s)

Body lean percentage [Time Frame: 16 weeks]

Mid-arm circumference [Time Frame: 16 weeks]

Body fat percentage [Time Frame: 16 weeks]

Triceps skin fold thickness [Time Frame: 16 weeks]

C-reactive protein [Time Frame: 16 weeks]

Corrected arm muscle area [Time Frame: 16 weeks]

Crohn's Disease Activity Index [Time Frame: 16 weeks]

Mid-arm muscle circumference [Time Frame: 16 weeks]

Pre-albumin [Time Frame: 16 weeks]

Serum albumin [Time Frame: 16 weeks]

Secondary ID(s)

CAAE: 1099.0.146.000-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fundação de Amparo à Pesquisa do Estado de São Paulo