Inguinal HerniaNCT03221686
Effects of Oral Supplementation of Arginine, Zinc and Vitamin C on Collagen Synthesis in Inguinal Hernia Patients
A study testing Intervention in people with Inguinal Hernia, run by Lars Nannestad Jorgensen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Feb 2016to 10 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years
- Patients undergoing hernia repair using the Lichtenstein technique
- Written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- Intervention, Control
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ControlDietary supplement
High quality protein supplement 14 days pre-operatively and post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Total daily protein intake: 1.5 g protein/kg body weight Receives: 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 Receives: Dietary Supplement: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
CICP is measured by enzyme-linked immunosorbent assay
Measured: 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).
CICP is measured by enzyme-linked immunosorbent assay
Measured: Day 0
Changes in Zinc levels in serum
Zinc is measured by direct spectrophotometry
Measured: Day -14, day 0, day 1 and day 2
Changes in Zinc levels in wound fluid collected from surgical drain
Zinc is measured by direct spectrophotometry
Measured: Day 1 and day 2
Changes in Zinc levels in wound fluid collected from suction blisters
Zinc is measured by direct spectrophotometry
Measured: Day 0
Changes in Arginine levels in serum
Arginine is measure by ultra-performance liquid chromatography and mass spectrometry
Measured: Day -14, day 0, day 1 and day 2
Healing of suction blisters
Clinical assessment
Measured: Day 3 to Suction Blister healing
Compliance
Count of remaining supplement
Measured: Day -14 to Suction Blister healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start20 Feb 2016
- Primary completionFeb 2017
- Study completion10 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Nannestad Jorgensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Nannestad Jorgensen, Bispebjerg Hospital
- Investigators
- Lars N Joergensen, Principal investigator, K. Forskning, BIspebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221686
- Sponsor's protocol ID
- H-15017272
- Status last verified
- Jul 2017
- First submitted
- 30 Mar 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31897483
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03221686
- Acronym / sponsor ID
- H-15017272
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lars Nannestad JorgensenUniversity, hospital or other
- Study start
- 20 Feb 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- 10 Dec 2017 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: ControlTotal daily protein intake: 1.5 g protein/kg body weight |
| Intervention | Active comparator | Dietary Supplement: Intervention55 mg zinc/day, 1251 mg vitamin C/day, and 15 g arginine/day. Total daily protein intake: 1.5 g protein/kg body weight |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18 years
- Patients undergoing hernia repair using the Lichtenstein technique
- Written informed consent
Key exclusion criteria (8 listed)
- Former surgery in the same area within 5 years
- Dementia
- Dysregulated diabetes
- Systemic corticosteroid treatment
- Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThe 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. | Dietary supplement | Intervention |
| ControlHigh quality protein supplement 14 days pre-operatively and post-operatively. | Dietary supplement | Control |
Primary outcome
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
8 secondary outcomes
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
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
Changes in Zinc levels in serum
Time frame: Day -14, day 0, day 1 and day 2
Changes in Zinc levels in wound fluid collected from surgical drain
Time frame: Day 1 and day 2
Changes in Zinc levels in wound fluid collected from suction blisters
Time frame: Day 0
Changes in Arginine levels in serum
Time frame: Day -14, day 0, day 1 and day 2
Healing of suction blisters
Time frame: Day 3 to Suction Blister healing
Compliance
Time frame: Day -14 to Suction Blister healing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Derived from this study: PubMed 31897483Kjaer 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.
- Individual participant dataSharing planned: No
Related trials for Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars N Joergensen principal investigator
K. Forskning, BIspebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Inguinal Hernia, run by Lars Nannestad Jorgensen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03221686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.