COVIDNCT04407572
Evaluation of the Relationship Between Zinc Vitamin D and b12 Levels in the Covid-19 Positive Pregnant Women
An observational study of COVID and Zinc Deficiency, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Zinc d vitamin and b12 serum levels in covid-19 positive pregnants will be compared in terms of patients' responses to computed tomography and treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID, Zinc Deficiency, Vitamin D Deficiency
- What is being tested?
- Serum zinc, vitamin d vitamin b12 levels .
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2020to 14 Jun 2020
- Phase
- Observational
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women between 18-45 years old with positive covid-19 pcr test results
Who may be able to join
- covid-19 positive pregnant women
- under 18 or more than 45 years old
Who cannot join
- vitamin D , Vitamin B12 or Zinc supplement use
- Multivitamine use
- have taken vitamin supplements in the past 3 months
- use of medicines for vitamin deficiency
- having metabolic disease covid-19 negative pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zinc Vitamin D and b12 Levels in the Covid-19 Positive Pregnant Women
Zinc d vitamin and b12 serum levels in covid-19 positive pregnants will be compared in terms of patients' responses to computed tomography and treatment.
Read the detailed description
Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.
- Conditions
- COVID, Zinc Deficiency, Vitamin D Deficiency
- Being tested
- Serum zinc, vitamin d vitamin b12 levels .
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum zinc, vitamin d vitamin b12 levels .Other
Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum zinc, vitamin d vitamin b12 deficiency levels
Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start20 Apr 2020
- Primary completion1 Jun 2020
- Study completion14 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ayşegül Bestel, İbrahim Polat, Merve Aldıkaçtıoğlu Talmaç
- Responsible party
- Principal investigator, Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407572
- Sponsor's protocol ID
- zinc-dvit-covid19
- Status last verified
- Jun 2020
- First submitted
- 27 May 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Vitamin D and b12 Levels in the Covid-19 Positive Pregnant Women
- ClinicalTrials.gov ID
- NCT04407572
- Acronym / sponsor ID
- zinc-dvit-covid19
- Conditions
- COVID, Zinc Deficiency, Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Collaborators
- Ayşegül Bestel, İbrahim Polat, Merve Aldıkaçtıoğlu Talmaç
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 14 Jun 2020 (actual)
- First posted
- 29 May 2020 (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.
Zinc d vitamin and b12 serum levels in covid-19 positive pregnants will be compared in terms of patients' responses to computed tomography and treatment.
Detailed description
Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women between 18-45 years old with positive covid-19 pcr test results
Key inclusion criteria (2 listed)
- covid-19 positive pregnant women
- under 18 or more than 45 years old
Key exclusion criteria (5 listed)
- vitamin D , Vitamin B12 or Zinc supplement use
- Multivitamine use
- have taken vitamin supplements in the past 3 months
- use of medicines for vitamin deficiency
- having metabolic disease covid-19 negative pregnant women
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 |
|---|---|---|
| Serum zinc, vitamin d vitamin b12 levels .Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients. | Other | – |
Primary outcome
Serum zinc, vitamin d vitamin b12 deficiency levels
Time frame: 2 months
Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.
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 23 Jun 2020.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Zinc Deficiency, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 23 Jun 2020. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Serum zinc, vitamin d vitamin b12 deficiency levels (time frame: 2 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 23 Jun 2020.