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

NCT ID: NCT03221686

Last Updated: 2018-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-20

Study Completion Date

2017-12-10

Brief Summary

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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

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control

Total daily protein intake: 1.5 g protein/kg body weight

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type ACTIVE_COMPARATOR

Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Control

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Lars Nannestad Jorgensen

OTHER

Sponsor Role lead

Responsible Party

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Lars Nannestad Jorgensen

Professor, MD, DrMedSci

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lars N Joergensen

Role: PRINCIPAL_INVESTIGATOR

K. Forskning, BIspebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, Copenhagen NV, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 31897483 (View on PubMed)

Other Identifiers

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H-15017272

Identifier Type: -

Identifier Source: org_study_id

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