Stress, PsychologicalPhase 4NCT04135378
Effect of Low Doses of Vitamin C on Salivary Cortisol , Heart Rate , Blood Pressure During Group Presentation
A Phase 4 study testing ascorbic acid in people with Stress, Psychological, run by Kufa University at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- ascorbic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIraq
- Study dates
- 1 Nov 2018to 20 Apr 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- students have a presentation
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
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 .
Read the 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) .
- Conditions
- Stress, Psychological
- Being tested
- ascorbic acid, placebo
- Keywords
- vitamin C , salivary cortisol , heart rate , blood pressure
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ascorbic acidDrug
Also called vitamin C
Study Group :- ascorbic acid ( 500 mg per day) for one week before presentation
placeboOther
:- included 30 students given placebo for one week before presentation.
| Study group | Role | What they receive |
|---|---|---|
| student- ascorbic acid | Experimental | Student that have presentation given ascorbic acid ( 500 mg per day) for one week before presentation . Receives: Drug: ascorbic acid |
| Control- ascorbic acid like | Placebo comparator | ascorbic acid like placebo for one week before presentation Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol
levels of cortisol in saliva between 3-19 microg/l
Measured: for six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Nov 2018
- Primary completion1 Mar 2019
- Study completion20 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kufa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali A. Al-fahham, Kufa University
- Investigators
- Ali A Al-fahham, Asst. Prof., Principal investigator, Kufa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135378
- Sponsor's protocol ID
- KufaU2
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Doses of Vitamin C on Salivary Cortisol , Heart Rate , Blood Pressure During Group Presentation
- ClinicalTrials.gov ID
- NCT04135378
- Acronym / sponsor ID
- KufaU2
- Conditions
- Stress, Psychological
- Keywords
- vitamin C , salivary cortisol , heart rate , blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kufa UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 20 Apr 2019 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 .
| Arm | Type | Receives |
|---|---|---|
| student- ascorbic acid | Experimental | Drug: ascorbic acidStudent that have presentation given ascorbic acid ( 500 mg per day) for one week before presentation . |
| Control- ascorbic acid like | Placebo comparator | Other: placeboascorbic acid like placebo for one week before presentation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- students have a presentation
Key exclusion criteria (1 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ascorbic acidAlso: vitamin CStudy Group :- ascorbic acid ( 500 mg per day) for one week before presentation | Drug | student- ascorbic acid |
| placebo:- included 30 students given placebo for one week before presentation. | Other | Control- ascorbic acid like |
Primary outcome
Cortisol
Time frame: for six months
levels of cortisol in saliva between 3-19 microg/l
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali A Al-fahham, Asst. Prof. principal investigator
Kufa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ascorbic acid in people with Stress, Psychological, run by Kufa University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol (time frame: for six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.