Osteopenia of PrematurityNCT03889717
Comparison of Two Different Doses of Vitamin D in Preterm Infants
A study testing vitamin D in people with Osteopenia of Prematurity, run by Cairo University at 1 site in Egypt.
Trial summary
randomized clinical trial comparing two different doses of vitamin d supplementation in preterm infants Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteopenia of Prematurity
- What is being tested?
- vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2019to 30 Jun 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Preterm infants delivered at a gestational age ≤ 32 weeks
- Birth weight ≤1500 kg
Who cannot join
- Neonates with major congenital anomalies,
- maternal condition or medications likely to influence vitamin D or calcium metabolism
- neonates not receiving 100 ml/ kg / day of enteral feeds by 14 days of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Two Regimens of Vitamin D Supplementation in Preterm Neonates
randomized clinical trial comparing two different doses of vitamin d supplementation in preterm infants
Read the detailed description
after randomization each group of preterm neonates (28-32) weeks consisting of 40 neonates
within 48 hrs of birth baseline ca.phosphorus, alkaline phosphatase and vitamin D level were withdrawn from each neonate
then babies started to take oral vitamin d in different doses (400 IU /day in the 1st group and 1000 iu per day in the 2nd group) after they reach 100 cc per kg per day enteral feeding
after they complete 40th week gestational age the investigators repeat the labs again ( serum ca, phosphorus,alp and vitamin D and compare the rate of rise in vitamin D and calcium
- Conditions
- Osteopenia of Prematurity
- Being tested
- 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.
vitamin DDietary supplement
vitamin d drops will be given daily to the 2 groups of neonates ( 1st group will be given 400 iu /day and 2nd group will be given 1000 iu per day ) when they reach 100 cc per kg enteral feeding .. until they reach 40 weeks gestational age
| Study group | Role | What they receive |
|---|---|---|
| 400 iu | Experimental | neonates who will receive vitamin d dose at 400 iu per day Receives: Dietary Supplement: vitamin D |
| 1000 iu | Active comparator | neonates who will receive vitamin d dose 1000 iu per day Receives: Dietary Supplement: vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the level of serum 25 hydroxy vitamin D between the two groups of newborns. 2- Detect vitamin D deficiency among both groups.
measurement of the level after supplementation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start16 Apr 2019
- Primary completion15 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
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 Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- after randomization ,two different groups of premature neonates are enrolled in the study baseline calcium,phosphorus and alp and vitamin D withdrawn at the 1st 48 hrs, then neonates started to administer vitamin D drops after they reached 100 cc per kg per day until they complete 40th week gestational age .follow up labs will be done at this age to determine which dose is better in vitamin d deficiency prevention
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Jamal Abd elmoez abd elmegeed Basta, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889717
- Sponsor's protocol ID
- DPTL
- Status last verified
- Apr 2019
- First submitted
- 22 Mar 2019
- Last updated
- 26 Apr 2019
- 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 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Two Regimens of Vitamin D Supplementation in Preterm Neonates
- ClinicalTrials.gov ID
- NCT03889717
- Acronym / sponsor ID
- DPTL
- Conditions
- Osteopenia of Prematurity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 26 Mar 2019 (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.
randomized clinical trial comparing two different doses of vitamin d supplementation in preterm infants
Detailed description
after randomization each group of preterm neonates (28-32) weeks consisting of 40 neonates
within 48 hrs of birth baseline ca.phosphorus, alkaline phosphatase and vitamin D level were withdrawn from each neonate
then babies started to take oral vitamin d in different doses (400 IU /day in the 1st group and 1000 iu per day in the 2nd group) after they reach 100 cc per kg per day enteral feeding
after they complete 40th week gestational age the investigators repeat the labs again ( serum ca, phosphorus,alp and vitamin D and compare the rate of rise in vitamin D and calcium
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- after randomization ,two different groups of premature neonates are enrolled in the study baseline calcium,phosphorus and alp and vitamin D withdrawn at the 1st 48 hrs, then neonates started to administer vitamin D drops after they reached 100 cc per kg per day until they complete 40th week gestational age .follow up labs will be done at this age to determine which dose is better in vitamin d deficiency prevention
| Arm | Type | Receives |
|---|---|---|
| 400 iu | Experimental | Dietary Supplement: vitamin Dneonates who will receive vitamin d dose at 400 iu per day |
| 1000 iu | Active comparator | Dietary Supplement: vitamin Dneonates who will receive vitamin d dose 1000 iu per day |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Preterm infants delivered at a gestational age ≤ 32 weeks
- Birth weight ≤1500 kg
Key exclusion criteria (3 listed)
- Neonates with major congenital anomalies,
- maternal condition or medications likely to influence vitamin D or calcium metabolism
- neonates not receiving 100 ml/ kg / day of enteral feeds by 14 days of life
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 Dvitamin d drops will be given daily to the 2 groups of neonates ( 1st group will be given 400 iu /day and 2nd group will be given 1000 iu per day ) when they reach 100 cc per kg enteral feeding .. until they reach 40 weeks gestational age | Dietary supplement | 1000 iu, 400 iu |
Primary outcome
Compare the level of serum 25 hydroxy vitamin D between the two groups of newborns. 2- Detect vitamin D deficiency among both groups.
Time frame: 1 month
measurement of the level after supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Individual participant dataSharing planned: Undecided
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RecruitingObservational study
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D in people with Osteopenia of Prematurity, run by Cairo 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 3 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 26 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina Basta, master (00201002866168, deena-gamal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the level of serum 25 hydroxy vitamin D between the two groups of newborns. 2- Detect vitamin D deficiency among both groups. (time frame: 1 month). 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 26 Apr 2019.