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

June 4, 2018 updated by: Lars Nannestad Jorgensen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen NV
      • Copenhagen, Copenhagen NV, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Total daily protein intake: 1.5 g protein/kg body weight
Dietary supplement: Control
High quality protein supplement 14 days pre-operatively and post-operatively.
Active Comparator: Intervention
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
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.

What is the study measuring?

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)
Time Frame: Day 2
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).
Time Frame: Day 1 and day 2
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).
Time Frame: Day 0
CICP is measured by enzyme-linked immunosorbent assay
Day 0
Changes in Zinc levels in serum
Time Frame: Day -14, day 0, day 1 and day 2
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
Time Frame: Day 1 and day 2
Zinc is measured by direct spectrophotometry
Day 1 and day 2
Changes in Zinc levels in wound fluid collected from suction blisters
Time Frame: Day 0
Zinc is measured by direct spectrophotometry
Day 0
Changes in Arginine levels in serum
Time Frame: Day -14, day 0, day 1 and day 2
Arginine is measure by ultra-performance liquid chromatography and mass spectrometry
Day -14, day 0, day 1 and day 2
Healing of suction blisters
Time Frame: Day 3 to Suction Blister healing
Clinical assessment
Day 3 to Suction Blister healing
Compliance
Time Frame: Day -14 to Suction Blister healing
Count of remaining supplement
Day -14 to Suction Blister healing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lars Nannestad Jorgensen

Investigators

  • Principal Investigator: Lars N Joergensen, K. Forskning, BIspebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

December 10, 2017

Study Registration Dates

First Submitted

March 30, 2017

First Submitted That Met QC Criteria

July 14, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15017272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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