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

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221686
• Other study ID #: H-15017272
• Status: Completed
• Phase: N/A
• Start date: February 20, 2016
• Est. completion date: December 10, 2017

Study information

• Verified date: July 2017
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 10, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Dietary Supplement:
• Intervention
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.
• Control
High quality protein supplement 14 days pre-operatively and post-operatively.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Copenhagen NV

Sponsors (1)

Lead Sponsor	Collaborator
Lars Nannestad Jorgensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Changes in Zinc levels in serum	Zinc is measured by direct spectrophotometry	Day -14, day 0, day 1 and day 2
Secondary	Changes in Zinc levels in wound fluid collected from surgical drain	Zinc is measured by direct spectrophotometry	Day 1 and day 2
Secondary	Changes in Zinc levels in wound fluid collected from suction blisters	Zinc is measured by direct spectrophotometry	Day 0
Secondary	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
Secondary	Healing of suction blisters	Clinical assessment	Day 3 to Suction Blister healing
Secondary	Compliance	Count of remaining supplement	Day -14 to Suction Blister healing