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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135378
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Ali A. Al-fahham, Kufa University

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:

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) .

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Study Type : Interventional  (Clinical Trial)
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 .
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 : November 1, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : April 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress Vitamin C

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 Name: 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.




Primary Outcome Measures :
  1. Cortisol [ Time Frame: for six months ]
    levels of cortisol in saliva between 3-19 microg/l



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 .


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135378


Locations
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Iraq
Kufa University
Najaf, Kufa, Iraq, 0964
Sponsors and Collaborators
Kufa University
Investigators
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Principal Investigator: Ali A Al-fahham, Asst. Prof. Kufa University
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Responsible Party: Ali A. Al-fahham, Assistance Professor, Kufa University
ClinicalTrials.gov Identifier: NCT04135378    
Other Study ID Numbers: KufaU2
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Ali A. Al-fahham, Kufa University:
vitamin C , salivary cortisol , heart rate , blood pressure
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms
Ascorbic Acid
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents