Osteopenia of PrematurityPhase 2NCT04768439
Low and High Doses of Prophylactic Vitamin D in Prevention of Osteopenia of Prematurity
A Phase 2 study testing Low Dose Vitamin D and High Dose Vitamin D in people with Osteopenia of Prematurity, run by Alexandria University at 1 site in Egypt.
Trial summary
In this study the effects of low and high doses of prophylactic vitamin D on biochemical and radiological manifestations of osetopenia of prematurity will be tested. Read more about this study
- Who is it for?
- Ages 1 day to 2 months
- Conditions the study is for
- Osteopenia of Prematurity
- What is being tested?
- Low Dose Vitamin D and High Dose Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2020to 30 Apr 2021
- 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 1 day to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with gestational age of ≤ 32 weeks and birth weight ≤ 1500 g.
Who cannot join
- Newborns whose mothers were taking specific medications interacting with vitamin D metabolism (e.g., anticonvulsants, diuretics)
- Being NPO (nothing per oral) for more than 2 wks
- Gestational age more than 32 weeks
- Birth weight more than 1500 grams
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Alexandria, 21131
About this study
Official title: Comparison Between Low and High Doses of Prophylactic Vitamin D in Prevention of Osteopenia of Prematurity
In this study the effects of low and high doses of prophylactic vitamin D on biochemical and radiological manifestations of osetopenia of prematurity will be tested.
Read the detailed description
The study will be conducted on (80) preterm infants that fulfill the eligibility criteria and delivered at Alexandria University Maternity Hospital (AUMH).
- Conditions
- Osteopenia of Prematurity
- Being tested
- Low Dose Vitamin D, High Dose Vitamin D
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Vitamin DDrug
Also called 1,25-Dihydroxycholecalciferol
Patients will receive a 200 IU/d vitamin D since they tolerate full enteral nutrition.
High Dose Vitamin DDrug
Also called 1,25-Dihydroxycholecalciferol
Patients will receive 1600 IU/d vitamin D since they tolerate full enteral nutrition.
| Study group | Role | What they receive |
|---|---|---|
| 200 IU/d vitamin D | Experimental | Patients will receive low-dose vitamin D (200 IU/d) Receives: Drug: Low Dose Vitamin D |
| 1600 IU/d vitamin D | Experimental | Patients will receive high-dose vitamin D (1600 IU/d) Receives: Drug: High Dose Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium level and activity
Serum calcium level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 8.5 to 10.5 mg/dl
Measured: six weeks
Phosphorus level and activity
Serum phosphorus level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 3.4 to 4.5 mg/dl
Measured: six weeks
Alkaline phosphatase level and activity
Serum alkaline phosphate level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 50-100 U/L.
Measured: six weeks
25-Hydroxy Vitamin D
Serum 25-Hydroxy Vitamin D level will be measured and analyzed using Electrochemilumiescence binding assay on cobas e immunoassay analyzer. The reference range of the total 25(OH)D level is 25-80 ng/mL.
Measured: six weeks
Bone fracture
This will be evaluated using an x-ray of left wrist
Measured: six weeks
Intracortical resorption
This will be evaluated using an x-ray of left wrist
Measured: six weeks
Losing the sharp bone border (fraying)
This will be evaluated using an x-ray of left wrist
Measured: six weeks
Cupping of metaphyseal edge of bone
This will be evaluated using an x-ray of left wrist
Measured: six weeks
Widening of the distal end of the metaphysis of bone
This will be evaluated using an x-ray of left wrist
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start10 Aug 2020
- Primary completion20 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenia of PrematurityStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Farag, Alexandria University
- Investigators
- Marwa M Farrag, PhD, Principal investigator, Faculty of Medicine, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768439
- Sponsor's protocol ID
- 00007555-00015712
- Status last verified
- Sep 2021
- First submitted
- 21 Feb 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Low and High Doses of Prophylactic Vitamin D in Prevention of Osteopenia of Prematurity
- ClinicalTrials.gov ID
- NCT04768439
- Acronym / sponsor ID
- 00007555-00015712
- Conditions
- Osteopenia of Prematurity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 24 Feb 2021 (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.
In this study the effects of low and high doses of prophylactic vitamin D on biochemical and radiological manifestations of osetopenia of prematurity will be tested.
Detailed description
The study will be conducted on (80) preterm infants that fulfill the eligibility criteria and delivered at Alexandria University Maternity Hospital (AUMH).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 200 IU/d vitamin D | Experimental | Drug: Low Dose Vitamin DPatients will receive low-dose vitamin D (200 IU/d) |
| 1600 IU/d vitamin D | Experimental | Drug: High Dose Vitamin DPatients will receive high-dose vitamin D (1600 IU/d) |
Who may qualify
- Ages
- 1 day to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborns with gestational age of ≤ 32 weeks and birth weight ≤ 1500 g.
Key exclusion criteria (4 listed)
- Newborns whose mothers were taking specific medications interacting with vitamin D metabolism (e.g., anticonvulsants, diuretics)
- Being NPO (nothing per oral) for more than 2 wks
- Gestational age more than 32 weeks
- Birth weight more than 1500 grams
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 |
|---|---|---|
| Low Dose Vitamin DAlso: 1,25-DihydroxycholecalciferolPatients will receive a 200 IU/d vitamin D since they tolerate full enteral nutrition. | Drug | 200 IU/d vitamin D |
| High Dose Vitamin DAlso: 1,25-DihydroxycholecalciferolPatients will receive 1600 IU/d vitamin D since they tolerate full enteral nutrition. | Drug | 1600 IU/d vitamin D |
Primary outcome
Calcium level and activity
Time frame: six weeks
Serum calcium level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 8.5 to 10.5 mg/dl
Phosphorus level and activity
Time frame: six weeks
Serum phosphorus level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 3.4 to 4.5 mg/dl
Alkaline phosphatase level and activity
Time frame: six weeks
Serum alkaline phosphate level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 50-100 U/L.
25-Hydroxy Vitamin D
Time frame: six weeks
Serum 25-Hydroxy Vitamin D level will be measured and analyzed using Electrochemilumiescence binding assay on cobas e immunoassay analyzer. The reference range of the total 25(OH)D level is 25-80 ng/mL.
Bone fracture
Time frame: six weeks
This will be evaluated using an x-ray of left wrist
Intracortical resorption
Time frame: six weeks
This will be evaluated using an x-ray of left wrist
Losing the sharp bone border (fraying)
Time frame: six weeks
This will be evaluated using an x-ray of left wrist
Cupping of metaphyseal edge of bone
Time frame: six weeks
This will be evaluated using an x-ray of left wrist
Widening of the distal end of the metaphysis of bone
Time frame: six weeks
This will be evaluated using an x-ray of left wrist
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 14 Sep 2021.
Related trials for Osteopenia of Prematurity
RecruitingObservational study
Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity
Exosomes, Newborn
Not yet recruiting
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
Vitamin D Deficiency, Osteopenia of Prematurity
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 Farrag, PhD principal investigator
Faculty of Medicine, Alexandria University, Egypt
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 Low Dose Vitamin D and High Dose Vitamin D in people with Osteopenia of Prematurity, run by Alexandria 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 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 14 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 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.
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?
Calcium level and activity (time frame: six weeks). The study lists 9 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 14 Sep 2021.