AutismPhase 2NCT02550912
A Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children
A Phase 2 study testing Vitamin D3 in people with Autism, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study to determine whether high dose vitamin D has positive effect on behavior of autistic children. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Autism
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2015to Mar 2016
- Phase
- Phase 2
- 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients fulfill fourth edition of Diagnostic and statistical manual of mental Disorders (DSM 4th) criteria for autism
Who cannot join
- Patients who had seizures within the past year or History of kidney or liver disease or Taking the following medications or supplements that may affect vitamin D level (as antiepileptic, corticosteroids or immunosuppressant) were excluded from the study. None of the study participants received vitamin D or calcium therapy in the past 6 months and there were no change in children's treatment regimen (including medications) within 1 month prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children
The purpose of this study to determine whether high dose vitamin D has positive effect on behavior of autistic children.
Read the detailed description
Double blinded placebo controlled study to determine effect of two different doses of vitamin D on Behavioral domains in autistic children.
- Conditions
- Autism
- Being tested
- Vitamin D3, Placebo
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called vitamin D drops
vitamin D drops for paediatrics
PlaceboOther
Also called glucose syrup
glucose syrup with same taste and color to vitamin D3 drops
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Active comparator | Patients will receive vitamin D drug with generic name: V drops manufactured by Medical Union Pharmaceuticals, Egypt Dosage form: liquid drops Dosage, frequency, and Duration:1000 international units per day for 3 months then 1000 international units per 25 pounds per day for another 3 months. Receives: Drug: Vitamin D3 |
| Placebo group | Placebo comparator | Patients will receive glucose syrup same taste and color as vitamin D3 drops with same dosage regimen to vitamin D group. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale)
Measured: At baseline, 12 weeks ,24 weeks
Effect of vitamin D on changes in behavioral measures (autism treatment evaluation checklist)
Measured: At baseline, 12 weeks ,24 weeks
Secondary outcomes (6)
Effect of vitamin D on calcium level
Measured: At baseline, 12 weeks ,24 weeks
Effect of vitamin D on phosphorous level
Measured: At baseline, 12 weeks ,24 weeks
Effect of vitamin D on alkaline phosphatase level
Measured: At baseline,12 weeks ,24 weeks
Effect of vitamin D on parathyroid hormone level
Measured: At baseline,12 weeks ,24 weeks
Effect of vitamin D on liver function test (alanine transaminase and aspartate transaminase)
Measured: At baseline, 12 weeks ,24 weeks
Effect of vitamin D on kidney function test (Blood urea nitrogen and serum creatinine)
Measured: At baseline, 12 weeks ,24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Farid Mohamed Fahmy, Ain Shams University
- Investigators
- sarah f mohamed fahmy, masters, Principal investigator, assistant lecturer clinical pharmacy ainshams universitynagwa A sabri, professor, Study director, professor in clinical pharmacy Ainshams universitymanal H elhamamsy, professor, Study director, professor in clinical pharmacy Ainshams universitymohamed A elsawi, professor, Study director, professor in pediatrics and genetics ainshams universityosama k zaki, consultant, Study director, medical consultant in paediatrics and genetics unit ainshams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550912
- Sponsor's protocol ID
- PhD(NO.18)
- Status last verified
- Jul 2016
- First submitted
- 12 Sep 2015
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children
- ClinicalTrials.gov ID
- NCT02550912
- Acronym / sponsor ID
- PhD(NO.18)
- Conditions
- Autism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Sep 2015 (estimated)
- 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 purpose of this study to determine whether high dose vitamin D has positive effect on behavior of autistic children.
Detailed description
Double blinded placebo controlled study to determine effect of two different doses of vitamin D on Behavioral domains in autistic children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Active comparator | Drug: Vitamin D3Patients will receive vitamin D drug with generic name: V drops manufactured by Medical Union Pharmaceuticals, Egypt Dosage form: liquid drops Dosage, frequency, and Duration:1000 international units per day for 3 months then 1000 international units per 25 pounds per day for another 3 months. |
| Placebo group | Placebo comparator | Other: PlaceboPatients will receive glucose syrup same taste and color as vitamin D3 drops with same dosage regimen to vitamin D group. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients fulfill fourth edition of Diagnostic and statistical manual of mental Disorders (DSM 4th) criteria for autism
Key exclusion criteria (1 listed)
- Patients who had seizures within the past year or History of kidney or liver disease or Taking the following medications or supplements that may affect vitamin D level (as antiepileptic, corticosteroids or immunosuppressant) were excluded from the study. None of the study participants received vitamin D or calcium therapy in the past 6 months and there were no change in children's treatment regimen (including medications) within 1 month prior to the study.
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 D3Also: vitamin D dropsvitamin D drops for paediatrics | Drug | Vitamin D group |
| PlaceboAlso: glucose syrupglucose syrup with same taste and color to vitamin D3 drops | Other | Placebo group |
Primary outcome
Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale)
Time frame: At baseline, 12 weeks ,24 weeks
Effect of vitamin D on changes in behavioral measures (autism treatment evaluation checklist)
Time frame: At baseline, 12 weeks ,24 weeks
6 secondary outcomes
Effect of vitamin D on calcium level
Time frame: At baseline, 12 weeks ,24 weeks
Effect of vitamin D on phosphorous level
Time frame: At baseline, 12 weeks ,24 weeks
Effect of vitamin D on alkaline phosphatase level
Time frame: At baseline,12 weeks ,24 weeks
Effect of vitamin D on parathyroid hormone level
Time frame: At baseline,12 weeks ,24 weeks
Effect of vitamin D on liver function test (alanine transaminase and aspartate transaminase)
Time frame: At baseline, 12 weeks ,24 weeks
Effect of vitamin D on kidney function test (Blood urea nitrogen and serum creatinine)
Time frame: At baseline, 12 weeks ,24 weeks
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 12 Jul 2016.
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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.
sarah f mohamed fahmy, masters principal investigator
assistant lecturer clinical pharmacy ainshams university
nagwa A sabri, professor study director
professor in clinical pharmacy Ainshams university
manal H elhamamsy, professor study director
professor in clinical pharmacy Ainshams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 in people with Autism, run by Ain Shams 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 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 12 Jul 2016. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale) (time frame: At baseline, 12 weeks ,24 weeks). The study lists 2 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 12 Jul 2016.