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

L

Lars Nannestad Jorgensen

Status

Completed

Conditions

Inguinal Hernia

Treatments

Dietary Supplement: Intervention
Dietary Supplement: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT03221686
H-15017272

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
Total daily protein intake: 1.5 g protein/kg body weight
Treatment:
Dietary Supplement: Control
Intervention
Active Comparator group
Description:
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
Treatment:
Dietary Supplement: Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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