Effect of an oral nutritional supplement therapy on muscle mass, bone metabolism, body composition, growth, and disease activity in pediatric Crohn’s Disease: a controlled trial
Not Applicable
- Conditions
- K50Crohn disease [regional enteritis]
- Registration Number
- DRKS00010278
- Lead Sponsor
- Klinikum der Universität München, Campus Großhadern
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
Diagnosis of CD, age 6 – 18 y , in clinical remission or with mild disease activity (weighted PCDAI = 40), on stable medical treatment, signed consent form obtained by guardians and ascent of participants
Exclusion Criteria
Patients will be excluded if they have undergone a major surgical resection of the small or large bowel (>20 cm), have cow’s milk protein allergy, have other chronic disease (liver, heart, renal etc.), have been treated with systemic corticosteroid, exclusive enteral nutrition, growth hormone or anabolic steroids in the last 3 months and/or require therapy intensification at the inclusion visit, or had bone density examination (DXA or pQCT) within 12 months prior to invitation to study participation.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in z-score cross sectional muscle area at the non-dominant forearm at baseline and after one year using pQCT (peripheral quantitative computed tomography). We hypothesise an increase in cross sectional muscle area of +0.5 z-scores in the intervention group compared to controls.
- Secondary Outcome Measures
Name Time Method