NCT03965637

Brief Summary

vitamin C or ascorbic acid has known role in tissue repair. due to it's properties(water\_soluble), vitamin c is not stored in the body and when depleted, the bleeding tendency will increase due to dysfunctional connective tissues production in vessel wall and it has some important functions in platelets.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

May 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 23, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

May 26, 2019

Last Update Submit

April 29, 2020

Conditions

Keywords

vitamin cHysterectomybleedingwound healingabdominal surgeries

Outcome Measures

Primary Outcomes (1)

  • volume of hemorrhage

    volume of hemorrhage during surgery

    During surgery

Secondary Outcomes (4)

  • Hemoglobin value

    6 and 24 hours after surgery

  • wound healing

    during 2 weeks post surgery

  • duration of stay in hospital

    up to 2 weeks post surgery

  • Infection

    up to 2 weeks post surgery

Study Arms (2)

vitamin C

EXPERIMENTAL

Intervention patients will be received double dose of Ascorbic acid via intravenous injection

Drug: vitamin C

Control

NO INTERVENTION

Control patients will not be received any intervention

Interventions

water-soluble vitamin C injection contain of 1000 mg vitamin C that given via intravenous injection

Also known as: ascorbic acid
vitamin C

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be 18 years and older
  • No smoking
  • No history of bleeding disorder
  • No history of favism
  • No history of uterus, ovary, cervical cancer

You may not qualify if:

  • Need to injection of vasopressor drugs
  • Surgeon disagreement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences

Tehran, Iran

Location

Related Publications (1)

  • Farahani-Jam S, Yaghmaei M, Vahdat Shariatpanahi Z. Effect of intravenous ascorbic acid administration on hemorrhage and wound complications in total abdominal hysterectomy: A prospective randomized clinical trial. Clin Nutr ESPEN. 2022 Jun;49:74-78. doi: 10.1016/j.clnesp.2022.03.024. Epub 2022 Mar 26.

MeSH Terms

Conditions

Hemorrhage

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • zahra vahdat shariatpanahi, MD,PhD

    Associatec professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2019

First Posted

May 29, 2019

Study Start

August 23, 2019

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

May 4, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations