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Nutritional Status and Body Composition of Adult Patients With Crohn's Disease

A Multi-center, Cross-sectional Observational Study on Nutritional Status and Body Composition of Adult Patients With Crohn's Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04915911
Enrollment
100
Registered
2021-06-07
Start date
2021-07-01
Completion date
2023-05-01
Last updated
2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Brief summary

Patients with Crohn's disease generally have nutritional risks and malnutrition. The investigators will conduct a multicenter cross-sectional study to discover nutritional status and body composition of Chinese adult patients with CD.

Detailed description

Several studies have found that the body composition of CD patients is related to disease and therapies. Due to lack of a prospective multicenter cross-sectional observational study on the nutritional status and body composition of adult patients with CD in China. Evaluating the nutritional status and body composition of these patients can help formulate individualized nutritional support strategies for adult CD patients.

Interventions

cross-sectional study

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years old; * diagnosis of CD; * Admission time \<48 hours; * Subject has voluntarily signed and dated an informed consent form.

Exclusion criteria

* Emergency surgery for intestinal fistula or abdominal abscess; * Unstable vital signs or unstable hemodynamics; * Pregnant or lactating women; * Admission to hospital due to other critical illnesses (such as tumor, HIV, severe infections requiring ventilator or CRRT treatment); * Dying patients whose life expectancy does not exceed 24 hours; * Severe liver insufficiency (liver function score 11-15 or total bilirubin\> 3mg/dL or tissue biopsy diagnosed as liver cirrhosis, hepatic encephalopathy, portal hypertension with history of gastrointestinal hemorrhage, etc.); * Severe renal insufficiency (creatinine value is 2 times higher than the upper limit of normal); * Severe metabolic diseases (such as metabolic syndrome, hyperthyroidism, etc.); * Patients whose burn area exceeds 20% of the body surface area; * Immunodeficiency, autoimmune disease, or receiving immunosuppressive treatment for diseases other than CD (such as organ transplantation, etc.); * Those who are not suitable for body composition analysis * Patients who have been selected for other clinical studies or have been selected for this study; * Subjects are unwilling to participate in this study or refuse to sign informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Appendicular skeletal mass indexWithin 48 hours of admission to hospitalBioelectrical impedance analysis

Secondary

MeasureTime frameDescription
Body compositionWithin 48 hours of admission to hospitalEspecially body fat mass by bioelectrical impedance analysis
Nutritional risk screeningWithin 48 hours of admission to hospitalDetect the presence of undernutrition and the risk of developing undernutrition by Risk Screening 2002 (NRS-2002), when score≥3, the patient is nutritionally at-risk
Nutritional assessmentWithin 48 hours of admission to hospitalDetect malnourished individuals by the Subjective Global Assessment (SGA) , where A is well nourished and C is severely malnourished
Grip strengthWithin 48 hours of admission to hospitalHand grip strength test

Countries

China

Contacts

Primary ContactPianhong Zhang, MS
zrlcyyzx@zju.edu.cn+86 8778 3852

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026