Effect of Low Doses of Vitamin C on Salivary Cortisol , Heart Rate , Blood Pressure During Group Presentation
Primary Purpose
Stress, Psychological
Status
Completed
Phase
Phase 4
Locations
Iraq
Study Type
Interventional
Intervention
ascorbic acid
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Psychological focused on measuring vitamin C , salivary cortisol , heart rate , blood pressure
Eligibility Criteria
Inclusion Criteria:
- students have a presentation
Exclusion Criteria:
- Exclusion criteria included : chronic diseases (DM , hypertension), hormonal disturbances, psychotic disorders, kidney stones and anemia . Students that have previous experience of public speaking were also excluded .
Sites / Locations
- Kufa University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
student- ascorbic acid
Control- ascorbic acid like
Arm Description
Student that have presentation given ascorbic acid ( 500 mg per day) for one week before presentation .
ascorbic acid like placebo for one week before presentation
Outcomes
Primary Outcome Measures
Cortisol
levels of cortisol in saliva between 3-19 microg/l
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04135378
Brief Title
Effect of Low Doses of Vitamin C on Salivary Cortisol , Heart Rate , Blood Pressure During Group Presentation
Official Title
Effect of Low Doses of Vitamin C on Salivary Cortisol , Heart Rate , Blood Pressure During Group Presentation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
April 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kufa University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 .
Detailed Description
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 .
The students were divided in to two groups :-
Study Group :- included 60 students given vitamin C ( 500 mg per day) for one week before presentation .
Placebo :- included 30 students given placebo for one week before presentation. Exclusion criteria included : chronic diseases (DM , hypertension), hormonal disturbances, psychotic disorders, kidney stones and anemia . Students that have previous experience of public speaking were also excluded .
Participants were asked to rinse their mouth with water before collecting saliva. A minimum volume of 1 mL saliva was obtained directly by expectorating into a collecting tube. Food and beverages such as tea, soft drinks, and coffee were not permitted 30 minutes prior to any sample collection. Because salivary cortisol concentration is independent of flow rate and sugarless gum does not interfere with the salivary assay, 21 participants were permitted to chew sugarless gum if needed to stimulate saliva flow. Participants were also instructed not to brush their teeth 30 minutes before saliva collection and to refrain from wearing lipstick on the day of saliva collection (Hellhammer et al., 1987) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
vitamin C , salivary cortisol , heart rate , blood pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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 .
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
student- ascorbic acid
Arm Type
Experimental
Arm Description
Student that have presentation given ascorbic acid ( 500 mg per day) for one week before presentation .
Arm Title
Control- ascorbic acid like
Arm Type
Placebo Comparator
Arm Description
ascorbic acid like placebo for one week before presentation
Intervention Type
Drug
Intervention Name(s)
ascorbic acid
Other Intervention Name(s)
vitamin C
Intervention Description
Study Group :- ascorbic acid ( 500 mg per day) for one week before presentation
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
:- included 30 students given placebo for one week before presentation.
Primary Outcome Measure Information:
Title
Cortisol
Description
levels of cortisol in saliva between 3-19 microg/l
Time Frame
for six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- students have a presentation
Exclusion Criteria:
- Exclusion criteria included : chronic diseases (DM , hypertension), hormonal disturbances, psychotic disorders, kidney stones and anemia . Students that have previous experience of public speaking were also excluded .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali A Al-fahham, Asst. Prof.
Organizational Affiliation
Kufa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kufa University
City
Najaf
State/Province
Kufa
ZIP/Postal Code
0964
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Low Doses of Vitamin C on Salivary Cortisol , Heart Rate , Blood Pressure During Group Presentation
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