Vitamin D DeficiencyNCT03258086
Vitamin D in Diabetic Children
A study testing blood sample test in people with Vitamin D Deficiency, run by Assiut University at 1 site in Egypt.
Trial summary
Vitamin D is so-called "sunshine vitamin",it is synthesized in the skin during exposure to the ultraviolet rays in sunlight so it has been suggested that ∼ 5-30 minutes of sun exposure between 10:00 a.m. and 3:00 p.m. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- blood sample test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2016to Sep 2017
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age (5 years - 15 years ).
- Type 1 diabetes patients.
Who cannot join
- Patients aged more than 15 years, less than 2 years.
- Type 2 diabetes.
- Neonatal diabetes.
- Patients with any complications from diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Vitamin D in Children With Type 1 Diabetes
Vitamin D is so-called "sunshine vitamin",it is synthesized in the skin during exposure to the ultraviolet rays in sunlight so it has been suggested that ∼ 5-30 minutes of sun exposure between 10:00 a.m. and 3:00 p.m. at least twice per week on the skin of the face, arms, back, or legs (without sunscreen) is usually adequate for vitamin D synthesis. Vitamin D is also found in plants (mainly mushrooms and yeast) and in a few foods such as fatty fish.
Vitamin D supplement is recommended in all infants until enough formula, milk, or other food sources are ingested to sufficiently provide 400 IU/day to prevent vitamin D deficiency. Type 1 diabetes is an autoimmune disease, and the self immune system plays a central role in the destruction of the beta cell of pancrease.
- Conditions
- Vitamin D Deficiency
- Being tested
- blood sample test
- 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.
blood sample testDiagnostic test
blood sample will be taken from all diabetic children for assessment of vitamin D level
| Study group | Role | What they receive |
|---|---|---|
| Blood sample | Experimental | 2ml blood sample of of blood will be taken for assessment of vitamin D Receives: Diagnostic Test: blood sample test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of vitamin D level (ng/ml)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Nov 2016
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258086
- Sponsor's protocol ID
- 17100043
- Status last verified
- Jan 2018
- First submitted
- 20 Aug 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vitamin D in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03258086
- Acronym / sponsor ID
- 17100043
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 23 Aug 2017 (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 D is so-called "sunshine vitamin",it is synthesized in the skin during exposure to the ultraviolet rays in sunlight so it has been suggested that ∼ 5-30 minutes of sun exposure between 10:00 a.m. and 3:00 p.m. at least twice per week on the skin of the face, arms, back, or legs (without sunscreen) is usually adequate for vitamin D synthesis. Vitamin D is also found in plants (mainly mushrooms and yeast) and in a few foods such as fatty fish.
Vitamin D supplement is recommended in all infants until enough formula, milk, or other food sources are ingested to sufficiently provide 400 IU/day to prevent vitamin D deficiency. Type 1 diabetes is an autoimmune disease, and the self immune system plays a central role in the destruction of the beta cell of pancrease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sample | Experimental | Diagnostic Test: blood sample test2ml blood sample of of blood will be taken for assessment of vitamin D |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age (5 years - 15 years ).
- Type 1 diabetes patients.
Key exclusion criteria (4 listed)
- Patients aged more than 15 years, less than 2 years.
- Type 2 diabetes.
- Neonatal diabetes.
- Patients with any complications from diabetes.
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 |
|---|---|---|
| blood sample testblood sample will be taken from all diabetic children for assessment of vitamin D level | Diagnostic test | Blood sample |
Primary outcome
Assessment of vitamin D level (ng/ml)
Time frame: 24 hours
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 9 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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 blood sample test in people with Vitamin D Deficiency, run by Assiut University at 1 site 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 2 inclusion and 4 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 9 Jan 2018. 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 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?
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?
Assessment of vitamin D level (ng/ml) (time frame: 24 hours). 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 9 Jan 2018.