Effects of Oral Supplementation of Arginine, Zinc and Vitamin C on Collagen Synthesis in Inguinal Hernia Patients
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
About this trial
This is an interventional basic science trial for Inguinal Hernia
Eligibility Criteria
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
Sites / Locations
- Bispebjerg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control
Intervention
Arm Description
Total daily protein intake: 1.5 g protein/kg body weight
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
CICP is measured by enzyme-linked immunosorbent assay
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).
CICP is measured by enzyme-linked immunosorbent assay
Changes in Zinc levels in serum
Zinc is measured by direct spectrophotometry
Changes in Zinc levels in wound fluid collected from surgical drain
Zinc is measured by direct spectrophotometry
Changes in Zinc levels in wound fluid collected from suction blisters
Zinc is measured by direct spectrophotometry
Changes in Arginine levels in serum
Arginine is measure by ultra-performance liquid chromatography and mass spectrometry
Healing of suction blisters
Clinical assessment
Compliance
Count of remaining supplement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03221686
Brief Title
Effects of Oral Supplementation of Arginine, Zinc and Vitamin C on Collagen Synthesis in Inguinal Hernia Patients
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 20, 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
December 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lars Nannestad Jorgensen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Total daily protein intake: 1.5 g protein/kg body weight
Arm Title
Intervention
Arm Type
Active Comparator
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
High quality protein supplement 14 days pre-operatively and post-operatively.
Primary Outcome Measure Information:
Title
Changes in CICP levels in serum. CICP is the biomarker of type I collagen synthesis (carboxy-terminal propeptide of type I procollagen)
Description
CICP is measured by enzyme-linked immunosorbent assay
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
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).
Description
CICP is measured by enzyme-linked immunosorbent assay
Time Frame
Day 1 and day 2
Title
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).
Description
CICP is measured by enzyme-linked immunosorbent assay
Time Frame
Day 0
Title
Changes in Zinc levels in serum
Description
Zinc is measured by direct spectrophotometry
Time Frame
Day -14, day 0, day 1 and day 2
Title
Changes in Zinc levels in wound fluid collected from surgical drain
Description
Zinc is measured by direct spectrophotometry
Time Frame
Day 1 and day 2
Title
Changes in Zinc levels in wound fluid collected from suction blisters
Description
Zinc is measured by direct spectrophotometry
Time Frame
Day 0
Title
Changes in Arginine levels in serum
Description
Arginine is measure by ultra-performance liquid chromatography and mass spectrometry
Time Frame
Day -14, day 0, day 1 and day 2
Title
Healing of suction blisters
Description
Clinical assessment
Time Frame
Day 3 to Suction Blister healing
Title
Compliance
Description
Count of remaining supplement
Time Frame
Day -14 to Suction Blister healing
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars N Joergensen
Organizational Affiliation
K. Forskning, BIspebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
State/Province
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31897483
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Oral Supplementation of Arginine, Zinc and Vitamin C on Collagen Synthesis in Inguinal Hernia Patients
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