Clinical trial NCT04989166: Effect of Nano-curcumin Supplementation in Acute Pancreatitis
Official title: Effect of Nano-curcumin Supplementation on Hospital Length of Stay, Clinical Outcomes,and Inflammation Level in Mild and Moderate Acute Pancreatitis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pancreatitis
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of nano-curcumin supplementation on hospital length of stay, clinical outcomes, and inflammation level in mild and moderate acute pancreatitis. 42 eligible patients with mild and moderate acute pancreatitis will randomly assign to consume two soft gels each containing 40 mg of nano-curcumin or placebo (control group) every morning and evening for two weeks. Both groups will also receive the standard medical treatment of acute pancreatitis according to relevant guidelines. Patient's blood samples and clinical outcomes will assess on days 0, 1, 2, 3, 4, and 14 of admission. The two groups will also be compared in terms of adverse events and hospital length of stay. Moreover, the patient's hospital readmission due to pancreatitis will be recorded within 90 days of hospitalization.

Detailed description: The dietary intake of patients will be examined by two non-consecutive 24-hour food recalls at baseline and end of the study. The patient's weight (kg) and Body Mass Index (BMI) will also be measured.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute pancreatitis by at least two of the three following criteria: 1) a history of acute abdominal pain 2) greater than the threefold elevation of the serum amylase and/or lipase level 3) computed tomographic evidence of acute pancreatitis
* Admission within 72 hours of onset of pain
* Age range of 18-75
* Ability to intake soft gels orally

Exclusion Criteria:

* Severe or critical AP on admission
* Pregnancy or lactation
* A history of allergy to curcumin
* Acute exacerbation of chronic pancreatitis
* Prior antioxidant therapy
* Severe co-morbid illness (liver disease including cirrhosis and hepatitis, Renal failure (Cr Cl \< 30 ml/min))
* Active infection
* Active malignancy
* Hyperthyroidism
* Persistent organ failure \> 48 hours (according to Marshall score)
* On anticoagulant/ anti platelet medications

Primary outcomes:
measure: Hospital length of stay
timeFrame: through study completion, up to 2 weeks
Secondary outcomes:
measure: Overall appetite
timeFrame: days 0, 1, 2, 3, 4, and 14 of admission
measure: Abdominal pain intensity
timeFrame: days 0, 1, 2, 3, 4, and 14 of admission
measure: CRP
timeFrame: days 0 and 14 of admission
measure: Analgesic medications
timeFrame: days 0, 1, 2, 3, 4, and 14
measure: Hospital readmission
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
Study officials:
References: