Clinical trial NCT03221686: Effects of Oral Supplementation of Arginine, Zinc and Vitamin C on Collagen Synthesis in Inguinal Hernia Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in CICP levels in serum. CICP is the biomarker of type I collagen synthesis (carboxy-terminal propeptide of type I procollagen)
timeFrame: Day 2
Secondary outcomes:
measure: 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).
timeFrame: Day 1 and day 2
measure: 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).
timeFrame: Day 0
measure: Changes in Zinc levels in serum
timeFrame: Day -14, day 0, day 1 and day 2
measure: Changes in Zinc levels in wound fluid collected from surgical drain
timeFrame: Day 1 and day 2
measure: Changes in Zinc levels in wound fluid collected from suction blisters
timeFrame: Day 0
measure: Changes in Arginine levels in serum
timeFrame: Day -14, day 0, day 1 and day 2
measure: Healing of suction blisters
timeFrame: Day 3 to Suction Blister healing
measure: Compliance
timeFrame: Day -14 to Suction Blister healing
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
Study officials:
affiliation: K. Forskning, BIspebjerg Hospital
name: Lars N Joergensen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kjaer M, Frederiksen AKS, Nissen NI, Willumsen N, van Hall G, Jorgensen LN, Andersen JR, Agren MS. Multinutrient Supplementation Increases Collagen Synthesis during Early Wound Repair in a Randomized Controlled Trial in Patients with Inguinal Hernia. J Nutr. 2020 Apr 1;150(4):792-799. doi: 10.1093/jn/nxz324.