Vitamin D DeficiencyPhase 4NCT06176157
Vitamin D Supplementation in Pediatrics. Oral or Parenteral! D2 or D3
A Phase 4 study testing vitamin D2, vitamin D3 in people with Vitamin D Deficiency, run by Ain Shams University.
Trial summary
A study will be performed on Vitamin D deficient/ insufficient Egyptian children to compare the efficacy of oral and parenteral forms of Ergocalciferol and cholecalciferol in raising serum 25(OH) D levels in these subjects Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- vitamin D2, vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Apr 2024
- Phase
- Phase 4
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- laboratory evidence of vitamin D deficiency or insufficiency without clinical signs of rickets
Who cannot join
- vitamin D or calcium supplementation within the last 6 months before inclusion, patients with diabetes mellitus, chronic liver disease and kidney disease, congenital or rheumatic heart disease, malabsorption syndromes, thyroid disease, juvenile rheumatic diseases, or other bone disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Vitamin D Supplementation in Vitamin D Deficient/Insufficient Children Oral or Parenteral! D2 or D3, A Randomized Controlled Trial.
A study will be performed on Vitamin D deficient/ insufficient Egyptian children to compare the efficacy of oral and parenteral forms of Ergocalciferol and cholecalciferol in raising serum 25(OH) D levels in these subjects
- Conditions
- Vitamin D Deficiency
- Being tested
- vitamin D2, vitamin D3
- Keywords
- Vitamin D, ergochalciferol, cholecalciferol, oral, parenteral
- 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.
vitamin D2, vitamin D3Dietary supplement
comparing parentral D2, D3, to oral D2, D3
| Study group | Role | What they receive |
|---|---|---|
| oral vitamin D2 group | Active comparator | Not described Receives: Dietary Supplement: vitamin D2, vitamin D3 |
| oral vitamin D3 group | Active comparator | Not described Receives: Dietary Supplement: vitamin D2, vitamin D3 |
| Parenteral vitamin D2 group | Active comparator | Not described Receives: Dietary Supplement: vitamin D2, vitamin D3 |
| Parenteral vitamin D3 group | Active comparator | Not described Receives: Dietary Supplement: vitamin D2, vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25(OH) D level after 1,2,3 months of supplementation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Magdy Hassan Nawar, Ain Shams University
- Investigators
- Marwa M Nawar, Lecturer, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176157
- Sponsor's protocol ID
- FMASU MS468/2023
- Status last verified
- Dec 2023
- First submitted
- 9 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After Publishing the research individual data will be available
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation in Vitamin D Deficient/Insufficient Children Oral or Parenteral! D2 or D3, A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06176157
- Acronym / sponsor ID
- FMASU MS468/2023
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, ergochalciferol, cholecalciferol, oral, parenteral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 19 Dec 2023 (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.
A study will be performed on Vitamin D deficient/ insufficient Egyptian children to compare the efficacy of oral and parenteral forms of Ergocalciferol and cholecalciferol in raising serum 25(OH) D levels in these subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| oral vitamin D2 group | Active comparator | Dietary Supplement: vitamin D2, vitamin D3 |
| oral vitamin D3 group | Active comparator | Dietary Supplement: vitamin D2, vitamin D3 |
| Parenteral vitamin D2 group | Active comparator | Dietary Supplement: vitamin D2, vitamin D3 |
| Parenteral vitamin D3 group | Active comparator | Dietary Supplement: vitamin D2, vitamin D3 |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- laboratory evidence of vitamin D deficiency or insufficiency without clinical signs of rickets
Key exclusion criteria (1 listed)
- vitamin D or calcium supplementation within the last 6 months before inclusion, patients with diabetes mellitus, chronic liver disease and kidney disease, congenital or rheumatic heart disease, malabsorption syndromes, thyroid disease, juvenile rheumatic diseases, or other bone disorders.
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 D2, vitamin D3comparing parentral D2, D3, to oral D2, D3 | Dietary supplement | Parenteral vitamin D2 group, Parenteral vitamin D3 group, oral vitamin D2 group, oral vitamin D3 group |
Primary outcome
serum 25(OH) D level after 1,2,3 months of supplementation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: Undecided. After Publishing the research individual data will be available
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
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.
Marwa M Nawar, Lecturer principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vitamin D2, vitamin D3 in people with Vitamin D Deficiency, run by Ain Shams University.
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 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Marwa M Nawar, Lecturer (+201005368647, marwa_magdy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum 25(OH) D level after 1,2,3 months of supplementation (time frame: 3 months). 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 19 Dec 2023.