NCT04135378

Brief Summary

Vitamin C (ascorbic acid) is a well-known antioxidant that is involved in anxiety, stress, depression, fatigue and mood state in humans . The purpose of this study is to investigate the effect of low doses of vitamin C on decreasing the level of public speaking stress in term of salivary cortisol , blood pressure (systolic and diastolic) and heart rate . A purposive sample of (90) were included in this randomized placeboled trial study (60 students were given 500 mg of vitamin c per day for one week a group presentation while 30 other students were given placebo for one week before a group presentation) . Salivary cortisol was measured by means of commercial immunoenzymatic kits . Blood pressure (systolic and diastolic) and heart rate were measured immediately before and after presentation .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

October 16, 2019

Last Update Submit

October 19, 2019

Conditions

Keywords

vitamin C , salivary cortisol , heart rate , blood pressure

Outcome Measures

Primary Outcomes (1)

  • Cortisol

    levels of cortisol in saliva between 3-19 microg/l

    for six months

Study Arms (2)

student- ascorbic acid

EXPERIMENTAL

Student that have presentation given ascorbic acid ( 500 mg per day) for one week before presentation .

Drug: ascorbic acid

Control- ascorbic acid like

PLACEBO COMPARATOR

ascorbic acid like placebo for one week before presentation

Other: placebo

Interventions

Study Group :- ascorbic acid ( 500 mg per day) for one week before presentation

Also known as: vitamin C
student- ascorbic acid
placeboOTHER

:- included 30 students given placebo for one week before presentation.

Control- ascorbic acid like

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- students have a presentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kufa University

Najaf, Kufa, 0964, Iraq

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Ali A Al-fahham, Asst. Prof.

    Kufa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental randomized placebo trial study approach was designed to meet the previously mentioned objectives of the current study. The period of the study is from 1st November 2018 to 20th April 2019. A random sample of (90) students was taken in this study .
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistance Professor

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 22, 2019

Study Start

November 1, 2018

Primary Completion

March 1, 2019

Study Completion

April 20, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations