Rotaviral GastroenteritisNCT07167797
Evaluation of the Role of Vitamin D in Reducing the Severity and Duration of Rotavirus Infection in Iraqi Children
A study testing Vitamin D (Cholecalciferol ) and Standard treatment for rotavirus in people with Rotaviral Gastroenteritis, run by University of Baghdad at 1 site in Iraq.
Trial summary
The aim of this study is to evaluate the effect of vitamin D supplementation on the clinical outcomes including duration and severity of rotavirus-induced gastroenteritis in children that will be admitted to the hospital. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Rotaviral Gastroenteritis
- What is being tested?
- Vitamin D (Cholecalciferol ) and Standard treatment for rotavirus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2025to 6 Dec 2025
- Phase
- Interventional
- 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 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with confirmed rotavirus infection by rotavirus stool examination by rotavirus rapid test from CerTest BIOTEC company in Spain.
- Serum vitamin D levels indicating deficiency (below 20 ng/mL)
Who cannot join
- Children with other major infections, severe dehydration or underlying health conditions.
- Children with current vitamin D supplementation.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the effect of vitamin D supplementation on the clinical outcomes including duration and severity of rotavirus-induced gastroenteritis in children that will be admitted to the hospital. And to evaluate the anti-inflammatory effect of vitamin D on the pediatrics with rotavirus gastroenteritis by measuring inflammatory markers such as C-reactive protein (CRP), neutrophil to lymphocyte ratio (NLR), platelet to lymphocytes ratio (PLR), lymphocytes to monocytes ratio (LMR) and mean platelet volume MPV.
Read the detailed description
Evaluation of effect of vitamin D supplementation on the clinical outcomes including duration and severity of rotavirus-induced gastroenteritis in children that will be admitted to the hospital. And to evaluate the anti-inflammatory effect of vitamin D on the pediatrics with rotavirus gastroenteritis by measuring inflammatory markers such as C-reactive protein (CRP), neutrophil to lymphocyte ratio (NLR), platelet to lymphocytes ratio (PLR), lymphocytes to monocytes ratio (LMR) and mean platelet volume MPV.
- Conditions
- Rotaviral Gastroenteritis
- Being tested
- Vitamin D (Cholecalciferol ), Standard treatment for rotavirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (Cholecalciferol )Dietary supplement
Group II (Treatment) group: received vitamin D single oral dose 100000 IU for age < 1 year and dose of 300000IU for age> 1 year in addition to standard treatment
Standard treatment for rotavirusDrug
Standard treatment for rotavirus which includes rehydration therapy and antipyretic therapy including sodium chloride fluid and paracetamol infusion
| Study group | Role | What they receive |
|---|---|---|
| Group I (control): received standard treatment which include rehydration therapy and antipyretic the | Placebo comparator | Group I (control): will receive standard treatment which include rehydration therapy and antipyretic therapy Receives: Drug: Standard treatment for rotavirus |
| Group II (Treatment) group: received vitamin D single oral dose 300000 IU for age < 1 year and dose | Experimental | Group II (Treatment) group: received vitamin D single oral dose 100000 IU for age < 1 year and dose of 300000IU for age> 1 year in addition to standard treatment. The study lasted 6 months, with follow-ups at 7-10 days Receives: Dietary Supplement: Vitamin D (Cholecalciferol ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of diarrhea
severity of diarrhea will be measured by frequency of daily bowel movement
Measured: 7 days
Duration of diarrhea
Duration of diarrhea will be measured by days
Measured: 7 days
Severity of vomiting
Severity of vomiting will be measured by frequency of vomiting per day
Measured: 7 days
Duration of vomiting
Duration of vomiting will be measured by days
Measured: 7 days
Hydration state
Hydration state will be measured by score (1 fore well hydrated,2 for mild dehydration, 3 for moderate dehydration and 4 for severe dehydration)
Measured: 7 days
Temperature
Temperature will be measured by nominal scale (1 for febrile and 0 fir afebrile patient)
Measured: 7 days
Secondary outcomes (5)
Measuring LMR at admission, after 4 days and after 7 days both groups.
Measuring LMR will be done by getting ratios of blood cells from CBC test
Measured: 7 days
C reactive protein (CRP)
CRP will be measured in mg/dl by CRP agglutination test
Measured: 7 days
Mean platelet volume (MPV)
Mean platelet volume (MPV) will be measured in femtoliter (fL)
Measured: 7 days
Measuring NLR at admission, after 4 days and after 7 days both groups.
Measuring NLR at admission, after 4 days and after 7 days both groups.
Measured: 7 days
Measuring PLR at admission, after 4 days and after 7 days both groups.
Measuring PLR at admission, after 4 days and after 7 days both groups.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Jan 2025
- Primary completion1 May 2025
- Study completion6 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotaviral GastroenteritisStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadia Thamir Ahmed, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167797
- Sponsor's protocol ID
- 1969
- Status last verified
- Dec 2025
- First submitted
- 21 Aug 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data such as clinical outcomes, laboratory data and demographic data
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Vitamin D in Reducing the Severity and Duration of Rotavirus Infection in Iraqi Children
- ClinicalTrials.gov ID
- NCT07167797
- Acronym / sponsor ID
- 1969
- Conditions
- Rotaviral Gastroenteritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 6 Dec 2025 (actual)
- First posted
- 11 Sep 2025 (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.
The aim of this study is to evaluate the effect of vitamin D supplementation on the clinical outcomes including duration and severity of rotavirus-induced gastroenteritis in children that will be admitted to the hospital. And to evaluate the anti-inflammatory effect of vitamin D on the pediatrics with rotavirus gastroenteritis by measuring inflammatory markers such as C-reactive protein (CRP), neutrophil to lymphocyte ratio (NLR), platelet to lymphocytes ratio (PLR), lymphocytes to monocytes ratio (LMR) and mean platelet volume MPV.
Detailed description
Evaluation of effect of vitamin D supplementation on the clinical outcomes including duration and severity of rotavirus-induced gastroenteritis in children that will be admitted to the hospital. And to evaluate the anti-inflammatory effect of vitamin D on the pediatrics with rotavirus gastroenteritis by measuring inflammatory markers such as C-reactive protein (CRP), neutrophil to lymphocyte ratio (NLR), platelet to lymphocytes ratio (PLR), lymphocytes to monocytes ratio (LMR) and mean platelet volume MPV.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (control): received standard treatment which include rehydration therapy and antipyretic the | Placebo comparator | Drug: Standard treatment for rotavirusGroup I (control): will receive standard treatment which include rehydration therapy and antipyretic therapy |
| Group II (Treatment) group: received vitamin D single oral dose 300000 IU for age < 1 year and dose | Experimental | Dietary Supplement: Vitamin D (Cholecalciferol )Group II (Treatment) group: received vitamin D single oral dose 100000 IU for age < 1 year and dose of 300000IU for age> 1 year in addition to standard treatment. The study lasted 6 months, with follow-ups at 7-10 days |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with confirmed rotavirus infection by rotavirus stool examination by rotavirus rapid test from CerTest BIOTEC company in Spain.
- Serum vitamin D levels indicating deficiency (below 20 ng/mL)
Key exclusion criteria (2 listed)
- Children with other major infections, severe dehydration or underlying health conditions.
- Children with current vitamin D supplementation.
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 |
|---|---|---|
| Vitamin D (Cholecalciferol )Group II (Treatment) group: received vitamin D single oral dose 100000 IU for age < 1 year and dose of 300000IU for age> 1 year in addition to standard treatment | Dietary supplement | Group II (Treatment) group: received vitamin D single oral dose 300000 IU for age < 1 year and dose |
| Standard treatment for rotavirusStandard treatment for rotavirus which includes rehydration therapy and antipyretic therapy including sodium chloride fluid and paracetamol infusion | Drug | Group I (control): received standard treatment which include rehydration therapy and antipyretic the |
Primary outcome
Severity of diarrhea
Time frame: 7 days
severity of diarrhea will be measured by frequency of daily bowel movement
Duration of diarrhea
Time frame: 7 days
Duration of diarrhea will be measured by days
Severity of vomiting
Time frame: 7 days
Severity of vomiting will be measured by frequency of vomiting per day
Duration of vomiting
Time frame: 7 days
Duration of vomiting will be measured by days
Hydration state
Time frame: 7 days
Hydration state will be measured by score (1 fore well hydrated,2 for mild dehydration, 3 for moderate dehydration and 4 for severe dehydration)
Temperature
Time frame: 7 days
Temperature will be measured by nominal scale (1 for febrile and 0 fir afebrile patient)
5 secondary outcomes
Measuring LMR at admission, after 4 days and after 7 days both groups.
Time frame: 7 days
C reactive protein (CRP)
Time frame: 7 days
Mean platelet volume (MPV)
Time frame: 7 days
Measuring NLR at admission, after 4 days and after 7 days both groups.
Time frame: 7 days
Measuring PLR at admission, after 4 days and after 7 days both groups.
Time frame: 7 days
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 31 Dec 2025.
- Individual participant dataSharing planned: Yes. Participant data such as clinical outcomes, laboratory data and demographic data
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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?
A study testing Vitamin D (Cholecalciferol ) and Standard treatment for rotavirus in people with Rotaviral Gastroenteritis, run by University of Baghdad 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 2 inclusion and 2 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 31 Dec 2025. 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.
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?
Severity of diarrhea (time frame: 7 days). The study lists 6 primary outcomes in all. 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 31 Dec 2025.