NCT03221686

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2017

Completed
Last Updated

June 6, 2018

Status Verified

July 1, 2017

Enrollment Period

12 months

First QC Date

March 30, 2017

Last Update Submit

June 4, 2018

Conditions

Inguinal Hernia

Outcome Measures

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)

    CICP is measured by enzyme-linked immunosorbent assay

    Day 2

Secondary Outcomes (8)

  • 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).

    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).

    Day 0

  • Changes in Zinc levels in serum

    Day -14, day 0, day 1 and day 2

  • Changes in Zinc levels in wound fluid collected from surgical drain

    Day 1 and day 2

  • Changes in Zinc levels in wound fluid collected from suction blisters

    Day 0

  • +3 more secondary outcomes

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Control

Intervention

ACTIVE COMPARATOR

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

Interventions

InterventionDIETARY_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.

Intervention
ControlDIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age above 18 years
  • Patients undergoing hernia repair using the Lichtenstein technique
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 31897483DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Methods

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Lars N Joergensen

    K. Forskning, BIspebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD, DrMedSci

Study Record Dates

First Submitted

March 30, 2017

First Posted

July 18, 2017

Study Start

February 20, 2016

Primary Completion

February 1, 2017

Study Completion

December 10, 2017

Last Updated

June 6, 2018

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)