Effects of Oral Supplementation of Arginine, Zinc and Vitamin C on Collagen Synthesis in Inguinal Hernia Patients

Study Overview
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Brief Summary
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Collagen synthesis is depressed systemically in the immediate postoperative period. Arginine, zinc and vitamin C impact collagen synthesis. The aim of this study is to investigate the effect of a pre and postoperative oral supplement consisting of arginine, zinc and vitamin C on collagen synthesis in patients undergoing inguinal hernia repair.

Detailed Description
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The trial investigates the effect of a pre and postoperative oral supplement consisting of arginine, zinc and vitamin C on collagen type I synthesis in patients undergoing inguinal hernia repair. The patients in the intervention group are given 55 mg zinc, 1251 mg vitamin C, and 15 g arginine once daily 14 days pre-operatively and post-operatively. Both groups receive high quality protein (1.5 g protein/kg body weight) daily during the same period. Hernia repair is done using the Lichtenstein technique. Drainage tubes are placed in the wound during the surgery. Epidermal wounds (10 mm) are made via the suction blister method on the ventral forearm of the patients on the day of surgery. Blood samples are drawn at day -14, day 0, day 1 and day 2. The surgical drain is emptied and fluid collected at day 1 and day 2.The healing of the suction blisters is assessed by clinical criteria until healing.

Official Title
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The Effect of a Pre- and Postoperative Oral Supplement of Arginine, Zinc and Vitamin C on Collagen Synthesis in Surgical Inguinal Hernia Patients: A Randomized Controlled Trial

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Dietary Supplement: Intervention
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 18 years Patients undergoing hernia repair using the Lichtenstein technique Written informed consent Exclusion Criteria: Former surgery in the same area within 5 years Dementia Dysregulated diabetes Systemic corticosteroid treatment Liver disease Kidney disease Cancer within 5 years Need of interpreter

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Total daily protein intake: 1.5 g protein/kg body weight | Dietary Supplement: Control<br>* High quality protein supplement 14 days pre-operatively and post-operatively.<br>|
| Active Comparator: Intervention<br>55 mg zinc/day, 1251 mg vitamin C/day, and 15 g arginine/day. Total daily protein intake: 1.5 g protein/kg body weight | Dietary Supplement: Intervention<br>* The patients in the intervention group are given 55 mg zinc, 1251 mg vitamin C, and 15 g arginine once daily 14 days pre-operatively and post-operatively together with a high quality protein supplement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in CICP levels in serum. CICP is the biomarker of type I collagen synthesis (carboxy-terminal propeptide of type I procollagen) | CICP is measured by enzyme-linked immunosorbent assay | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in CICP levels in wound fluid collected from surgical drain. CICP is the biomarker of type I collagen synthesis (carboxy-terminal propeptide of type I procollagen). | CICP is measured by enzyme-linked immunosorbent assay | Day 1 and day 2 | 
| Changes in CICP levels in wound fluid collected from suction blisters. CICP is the biomarker of type I collagen synthesis (carboxy-terminal propeptide of type I procollagen). | CICP is measured by enzyme-linked immunosorbent assay | Day 0 | 
| Changes in Zinc levels in serum | Zinc is measured by direct spectrophotometry | Day -14, day 0, day 1 and day 2 | 
| Changes in Zinc levels in wound fluid collected from surgical drain | Zinc is measured by direct spectrophotometry | Day 1 and day 2 | 
| Changes in Zinc levels in wound fluid collected from suction blisters | Zinc is measured by direct spectrophotometry | Day 0 | 
| Changes in Arginine levels in serum | Arginine is measure by ultra-performance liquid chromatography and mass spectrometry | Day -14, day 0, day 1 and day 2 | 
| Healing of suction blisters | Clinical assessment | Day 3 to Suction Blister healing | 
| Compliance | Count of remaining supplement | Day -14 to Suction Blister healing |