EpilepsyPhase 3NCT03536845
Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy
A Phase 3 study testing Vitamin D 3 in people with Epilepsy and Vitamin D Deficiency, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
To determine the maintenance dose of vitamin D supplementation required for children with epilepsy to maintain normal vitamin D level. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Epilepsy, Vitamin D Deficiency
- What is being tested?
- Vitamin D 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2018to 1 Aug 2021
- Phase
- Phase 3
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 2-16 years who were diagnosed with Epilepsy and being treated with AEDs
- Followed up in the outpatient pediatric neurology clinic at King Khalid University Hospital during the period of two years.
Who cannot join
- Children with pre-existing vitamin D metabolism problems; because they are known to need different vitamin D doses and monitoring for clinical improvement:
- Vitamin D dependent rickets
- Malabsorption syndromes like celiac disease, inflammatory bowel disease
- Renal disease
- Hepatic disease
- Children who are not safe to start vitamin D supplementation; because vitamin D supplementation will causes toxicity and induces nephrocalcinosis:
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- Hypercalcemia at baseline total corrected calcium >2.5mg/dl
- Vitamin D level > 250 nmol/L
- Urine calcium: creatinine ration > 1.2 mol/mol, or > 0.41g/g.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy: a Randomized Controlled Clinical Trial
To determine the maintenance dose of vitamin D supplementation required for children with epilepsy to maintain normal vitamin D level.
Read the detailed description
children aged 2-16 years diagnosed with idiopathic epilepsy will be randomized to receive either cholecalciferol doses (400IU vs 1000IU) with follow up at 3 and 6 months post supplementation.
- Conditions
- Epilepsy, Vitamin D Deficiency
- Being tested
- Vitamin D 3
- Medical subject headings
- Epilepsy, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D 3Drug
oral drops
| Study group | Role | What they receive |
|---|---|---|
| 400 IU | Active comparator | Not described Receives: Drug: Vitamin D 3 |
| 1000 IU | Active comparator | Not described Receives: Drug: Vitamin D 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D level < 75 nmol/L
Measured: 6 months of supplementation
Secondary outcomes (4)
Seizure rate
Measured: 6 months of supplementation
bone mineral density (BMD) measurement
Measured: 6 months of supplementation
Cost- effectiveness of vitamin D supplementation
cost of vitamin D supplementation compared to the cost of poor bone health, hospital admission
Measured: 6 months of supplementation
Safety: Prevalence of hypercalcemia total calcium >2.7mg/dl, 25 OH vit D level> 250 nmol/l, and Urine calcium: creatinine ration > 1.2 mol/mol, or > 0.41g/g.
Measured: 6 months of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start1 Jan 2018
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- Dallah hospital
- Responsible party
- Principal investigator, Reem Al Khalifah, King Saud University
- Investigators
- Reem Al Khalifah, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536845
- Sponsor's protocol ID
- E-17-2425
- Status last verified
- Sep 2021
- First submitted
- 14 May 2018
- Last updated
- 13 Sep 2021
- 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 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03536845
- Acronym / sponsor ID
- E-17-2425
- Conditions
- Epilepsy, Vitamin D Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- Dallah hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 25 May 2018 (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.
To determine the maintenance dose of vitamin D supplementation required for children with epilepsy to maintain normal vitamin D level.
Detailed description
children aged 2-16 years diagnosed with idiopathic epilepsy will be randomized to receive either cholecalciferol doses (400IU vs 1000IU) with follow up at 3 and 6 months post supplementation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 400 IU | Active comparator | Drug: Vitamin D 3 |
| 1000 IU | Active comparator | Drug: Vitamin D 3 |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged between 2-16 years who were diagnosed with Epilepsy and being treated with AEDs
- Followed up in the outpatient pediatric neurology clinic at King Khalid University Hospital during the period of two years.
Key exclusion criteria (9 listed)
- Children with pre-existing vitamin D metabolism problems; because they are known to need different vitamin D doses and monitoring for clinical improvement:
- Children who are not safe to start vitamin D supplementation; because vitamin D supplementation will causes toxicity and induces nephrocalcinosis:
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 3oral drops | Drug | 1000 IU, 400 IU |
Primary outcome
Vitamin D level < 75 nmol/L
Time frame: 6 months of supplementation
4 secondary outcomes
Seizure rate
Time frame: 6 months of supplementation
bone mineral density (BMD) measurement
Time frame: 6 months of supplementation
Cost- effectiveness of vitamin D supplementation
Time frame: 6 months of supplementation
Safety: Prevalence of hypercalcemia total calcium >2.7mg/dl, 25 OH vit D level> 250 nmol/l, and Urine calcium: creatinine ration > 1.2 mol/mol, or > 0.41g/g.
Time frame: 6 months of supplementation
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 13 Sep 2021.
- 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.
Reem Al Khalifah principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D 3 in people with Epilepsy and Vitamin D Deficiency, run by King Saud University at 1 site in Saudi Arabia.
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 9 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 13 Sep 2021. 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 Saudi Arabia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Vitamin D level < 75 nmol/L (time frame: 6 months of supplementation). 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 13 Sep 2021.