Giardia Lamblia InfectionNCT04778280
Vitamin D Estimation With Giardia Lamblia Infections
An observational study of Giardia Lamblia Infection, run by Sohag University at 2 sites in Egypt.
Trial summary
investigators will take stool and blood samples from two groups of humans :- 1-group A (healthy group negative Giardia or control group),2-group B (positive Giardia or case group)then investigators make estimation for vitamin D in both groups then investigators try to find if there is relation between vitamin D level… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Giardia Lamblia Infection
- How many people
- 192 participants
- Where
- 2 sitesEgypt
- Study dates
- 17 Feb 2021to Feb 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: we take 192 samples then we will divide these samples into two groups :- 1. Group A (healty group with negative Giardia lamblia or control group) 2. Group B ( diseased group with positive Giardia lamblia or cases group)
Who may be able to join
- patient infected with Giardia lamblia.
Who cannot join
- patient takes vitamin D supplement - patient has kidney disease- patient has liver disease-patient has a debilitating disease disease such as cancer or diabetes.
Trial locations and contacts
2 sites in 1 country.
Noha Sammer Ahmed, Assist prof contact
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of Medicine Sohag University
Sohag
Mohammed Sayed Farrag, Demonstrator, 01110054887, mohameds_post@med.sohag.edu.eg
Mohammed Sayed Farrag, Demonstrator
- Recruiting
Faculty of Medicine
Sohag
Mohammed sayed farrag, demonstrator, 01110054887, mohameds_post@med.sohag.edu.eg
Noha sammer ahmed, assist prof, 01273126001
About this study
Official title: Estimation of Vitamin D in Humans Infected With Giardia Lamblia
investigators will take stool and blood samples from two groups of humans :-
1-group A (healthy group negative Giardia or control group),2-group B (positive Giardia or case group)then investigators make estimation for vitamin D in both groups then investigators try to find if there is relation between vitamin D level and Giardia lamblia infections
Read the detailed description
In this research a case- control study will be used) ,the percentage of case to control will be 1:1 the total number of samples 192 ,investigators will take stool and blood samples from two groups of humans :-
1-group A (healthy group negative Giardia or control group),2-group B (positive Giardia or case group)then investigators make estimation for vitamin D in both groups then investigators try to find if there is relation between vitamin D level and Giardia lamblia infections
- Conditions
- Giardia Lamblia Infection
- Keywords
- estimaion of vitamin D in humans infected with Giardia lamblia
- Medical subject headings
- Giardiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 1-Group A(Healty group with negative Giardia lamblia or control group) 96 samples | |
| Group B | 2- Group B(Cases group with positive Giardia lamblia )96 sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluctuation level of vitamin D level
Estimation of vitamin D level in humans infected with Giardia lamblia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start17 Feb 2021
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giardia Lamblia InfectionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sayed Farrag, Sohag University
- Investigators
- Mohammed Sayed Farrag, Demonstrator, Principal investigator, faculty of medicine sohag universityMohammed Sayed Farrag, Demonstrator, Study director, faculty of medicine sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778280
- Sponsor's protocol ID
- Soh-Med-21-02-17
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Vitamin D in Humans Infected With Giardia Lamblia
- ClinicalTrials.gov ID
- NCT04778280
- Acronym / sponsor ID
- Soh-Med-21-02-17
- Conditions
- Giardia Lamblia Infection
- Keywords
- estimaion of vitamin D in humans infected with Giardia lamblia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 3 Mar 2021 (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.
investigators will take stool and blood samples from two groups of humans :-
1-group A (healthy group negative Giardia or control group),2-group B (positive Giardia or case group)then investigators make estimation for vitamin D in both groups then investigators try to find if there is relation between vitamin D level and Giardia lamblia infections
Detailed description
In this research a case- control study will be used) ,the percentage of case to control will be 1:1 the total number of samples 192 ,investigators will take stool and blood samples from two groups of humans :-
1-group A (healthy group negative Giardia or control group),2-group B (positive Giardia or case group)then investigators make estimation for vitamin D in both groups then investigators try to find if there is relation between vitamin D level and Giardia lamblia infections
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –1-Group A(Healty group with negative Giardia lamblia or control group) 96 samples |
| Group B | – | –2- Group B(Cases group with positive Giardia lamblia )96 sample |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- we take 192 samples then we will divide these samples into two groups :- 1. Group A (healty group with negative Giardia lamblia or control group) 2. Group B ( diseased group with positive Giardia lamblia or cases group)
Key inclusion criteria (1 listed)
- patient infected with Giardia lamblia.
Key exclusion criteria (1 listed)
- patient takes vitamin D supplement - patient has kidney disease- patient has liver disease-patient has a debilitating disease disease such as cancer or diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fluctuation level of vitamin D level
Time frame: 1 year
Estimation of vitamin D level in humans infected with Giardia lamblia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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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.
Noha Sammer Ahmed, Assist prof contact
Mohammed Sayed Farrag, Demonstrator principal investigator
faculty of medicine sohag university
Mohammed Sayed Farrag, Demonstrator study director
faculty of medicine sohag university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giardia Lamblia Infection, run by Sohag University at 2 sites in Egypt.
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: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Sayed Farrag, Demonstrator (01110054887, mohameds_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluctuation level of vitamin D level (time frame: 1 year). 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 3 Mar 2021.