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Completed

NCT Number: NCT03221686

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

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Dietary Supplement

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

Dietary Supplement

High quality protein supplement 14 days pre-operatively and post-operatively.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  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

  3. Changes in Zinc levels in serum

    Time frame: Day -14, day 0, day 1 and day 2

    Zinc is measured by direct spectrophotometry

  4. Changes in Zinc levels in wound fluid collected from surgical drain

    Time frame: Day 1 and day 2

    Zinc is measured by direct spectrophotometry

  5. Changes in Zinc levels in wound fluid collected from suction blisters

    Time frame: Day 0

    Zinc is measured by direct spectrophotometry

  6. 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

  7. Healing of suction blisters

    Time frame: Day 3 to Suction Blister healing

    Clinical assessment

  8. Compliance

    Time frame: Day -14 to Suction Blister healing

    Count of remaining supplement

Sponsors and collaborators

Lead sponsor

Lars Nannestad Jorgensen

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2017
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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