Effect of Low Doses of Vitamin C on Salivary Cortisol , Heart Rate , Blood Pressure During Group Presentation
|ClinicalTrials.gov Identifier: NCT04135378|
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stress, Psychological||Drug: ascorbic acid Other: placebo||Phase 4|
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) .
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|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)|
|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|
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
:- included 30 students given placebo for one week before presentation.
- Cortisol [ Time Frame: for six months ]levels of cortisol in saliva between 3-19 microg/l
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135378
|Najaf, Kufa, Iraq, 0964|
|Principal Investigator:||Ali A Al-fahham, Asst. Prof.||Kufa University|