Effect of Low Doses of Vitamin C on Salivary Cortisol , Heart Rate , Blood Pressure During Group Presentation

Sponsor

Kufa University (Other)

Overall Status

Completed

CT.gov ID

NCT04135378

Collaborator

(none)

Enrollment

Location

Arms

5.6

Actual Duration (Months)

16.1

Patients Per Site Per Month

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Stress, Psychological	Drug: ascorbic acid Other: placebo	Phase 4

Detailed Description

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) .

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 .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)

Primary Purpose:

Treatment

Official Title:

Effect of Low Doses of Vitamin C on Salivary Cortisol , Heart Rate , Blood Pressure During Group Presentation

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Apr 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: student- ascorbic acid Student that have presentation given ascorbic acid ( 500 mg per day) for one week before presentation .	Drug: ascorbic acid Study Group :- ascorbic acid ( 500 mg per day) for one week before presentation Other Names: vitamin C
Placebo Comparator: Control- ascorbic acid like ascorbic acid like placebo for one week before presentation	Other: placebo :- included 30 students given placebo for one week before presentation.

Arm

Intervention/Treatment

Experimental: student- ascorbic acid

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

Drug: ascorbic acid

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

Other Names:

vitamin C

Placebo Comparator: Control- ascorbic acid like

ascorbic acid like placebo for one week before presentation

Other: placebo

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

Outcome Measures

Primary Outcome Measures

Cortisol [for six months]
levels of cortisol in saliva between 3-19 microg/l

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kufa University	Najaf	Kufa	Iraq	0964

Sponsors and Collaborators

Kufa University

Investigators

Principal Investigator: Ali A Al-fahham, Asst. Prof., Kufa University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ali A. Al-fahham, Assistance Professor, Kufa University

ClinicalTrials.gov Identifier:

NCT04135378

Other Study ID Numbers:

KufaU2

First Posted:

Oct 22, 2019

Last Update Posted:

Oct 22, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Ali A. Al-fahham, Assistance Professor, Kufa University

vitamin C , salivary cortisol , heart rate , blood pressure

Additional relevant MeSH terms:

Stress, Psychological

Ascorbic Acid

Study Results

No Results Posted as of Oct 22, 2019