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

NCT ID: NCT04135378

Last Updated: 2019-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-04-20

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 :-

1. Study Group :- included 60 students given vitamin C ( 500 mg per day) for one week before presentation .

2. 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) .

Conditions

Stress, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

student- ascorbic acid

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

Group Type: EXPERIMENTAL

ascorbic acid

Intervention Type: DRUG

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

Control- ascorbic acid like

ascorbic acid like placebo for one week before presentation

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

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

Interventions

ascorbic acid

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

Intervention Type: DRUG

placebo

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

Intervention Type: OTHER

Other Intervention Names

vitamin C

Eligibility Criteria

Inclusion Criteria

• students have a presentation

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kufa University

OTHER

Sponsor Role: lead

Responsible Party

Ali A. Al-fahham

Assistance Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali A Al-fahham, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Kufa University

Locations

Kufa University

Najaf, Kufa, Iraq

Countries

Iraq

Other Identifiers

KufaU2

Identifier Type: -

Identifier Source: org_study_id