Vitamin D SupplementationNCT06674122
Efficacy of Higher Dose Enteral Vitamin D Supplementation in Preterm 28 - 34 Weeks of Gestational Age
A study testing Enteral vitamin D supplementation of 800 IU/day and Enteral vitamin D supplementation of 400 IU/day in people with Vitamin D Supplementation, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn about the effective dosage of enteral vitamin D supplementation in preterm infants with gestational age fom 28 to 34 weeks. The main questions it aims to answer is: Does higher dose of enteral vitamin D supplementation (800IU/day) increase vitamin D level better than… Read more about this study
- Who is it for?
- Ages 28 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Supplementation
- What is being tested?
- Enteral vitamin D supplementation of 800 IU/day and Enteral vitamin D supplementation of 400 IU/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Jul 2024to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 28 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- neonates with gestational age 28-34 weeks
- tolerated enteral feedings more than 30ml/kg
Who cannot join
- infants with major congenital anomaly
- infants with gastrointestinal obstruction
- infants with congenital renal failure
- infants with cholestassis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy of Enteral Vitamin D Supplementation at a Dose of 800 IU Compared to 400 IU in Preterm Infants With a Gestational Age of 28-34 Weeks Admitted to the Neonatal Care Unit
The goal of this clinical trial is to learn about the effective dosage of enteral vitamin D supplementation in preterm infants with gestational age fom 28 to 34 weeks. The main questions it aims to answer is:
- Does higher dose of enteral vitamin D supplementation (800IU/day) increase vitamin D level better than standard recommended dose (400IU/day) to achieve sufficient level of vitamin D?
Participants will:
- Take the enteral vitamin D supplementation every fay for 28 days
- Have their blood level of vitamin D examined before and after supplementation for 28 days
Read the detailed description
The study conducted in 2 hospitals in Jakarta region, RSCM and RSUD Koja. Preterm with 28 to 34 weeks of gestational age and fulfill the inclusion criteria will be enrolled in the study after parents signed the informed consent.
Blood sample will be collected to get the baseline of vitamin D serum. The study subject will be given enteral vitamin D supplementation for 28 days (4 weeks). The dosage of vitamin D is randomized with block randomized in sealed envelope.
Subjects then will be followed up to 28 days of supplementation. After 28 days of supplementation, the subjects' blood will be collected to get the vitamin D serum level. Data taken will be analyzed using IBM Statistical Product and Service Solutions (SPSS).
- Conditions
- Vitamin D Supplementation
- Being tested
- Enteral vitamin D supplementation of 800 IU/day, Enteral vitamin D supplementation of 400 IU/day
- Keywords
- vitamin D supplementation in preterm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral vitamin D supplementation of 800 IU/dayDietary supplement
Higher dose of enteral vitamin D supplementations (800 IU/day) are given for 28 days, and vitamin D status are examined before and after supplementation
Enteral vitamin D supplementation of 400 IU/dayDietary supplement
Standard recommended dose of enteral vitamin D supplementations (400 IU/day) are given for 28 days, and vitamin D status are examined before and after supplementation
| Study group | Role | What they receive |
|---|---|---|
| 400 IU | Active comparator | Participants will receive enteral vitamin D supplementation of 400 IU/day for 28 days Receives: Dietary Supplement: Enteral vitamin D supplementation of 400 IU/day |
| 800 IU | Experimental | Participants will receive enteral vitamin D supplementation of 800 IU/day for 28 days Receives: Dietary Supplement: Enteral vitamin D supplementation of 800 IU/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH)D level
serum level of 25(OH)D
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start17 Jul 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion10 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D SupplementationStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosalina Dewi Roeslani, Universitas Indonesia
- Investigators
- Rosalina D Roeslani, dr, SpA(K), Principal investigator, FKUI RSCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674122
- Sponsor's protocol ID
- VitD800vs400
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 6 Nov 2024
- 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 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Enteral Vitamin D Supplementation at a Dose of 800 IU Compared to 400 IU in Preterm Infants With a Gestational Age of 28-34 Weeks Admitted to the Neonatal Care Unit
- ClinicalTrials.gov ID
- NCT06674122
- Acronym / sponsor ID
- VitD800vs400
- Conditions
- Vitamin D Supplementation
- Keywords
- vitamin D supplementation in preterm
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 10 Mar 2025 (estimated)
- First posted
- 5 Nov 2024 (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.
The goal of this clinical trial is to learn about the effective dosage of enteral vitamin D supplementation in preterm infants with gestational age fom 28 to 34 weeks. The main questions it aims to answer is:
- Does higher dose of enteral vitamin D supplementation (800IU/day) increase vitamin D level better than standard recommended dose (400IU/day) to achieve sufficient level of vitamin D?
Participants will:
- Take the enteral vitamin D supplementation every fay for 28 days
- Have their blood level of vitamin D examined before and after supplementation for 28 days
Detailed description
The study conducted in 2 hospitals in Jakarta region, RSCM and RSUD Koja. Preterm with 28 to 34 weeks of gestational age and fulfill the inclusion criteria will be enrolled in the study after parents signed the informed consent.
Blood sample will be collected to get the baseline of vitamin D serum. The study subject will be given enteral vitamin D supplementation for 28 days (4 weeks). The dosage of vitamin D is randomized with block randomized in sealed envelope.
Subjects then will be followed up to 28 days of supplementation. After 28 days of supplementation, the subjects' blood will be collected to get the vitamin D serum level. Data taken will be analyzed using IBM Statistical Product and Service Solutions (SPSS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 400 IU | Active comparator | Dietary Supplement: Enteral vitamin D supplementation of 400 IU/dayParticipants will receive enteral vitamin D supplementation of 400 IU/day for 28 days |
| 800 IU | Experimental | Dietary Supplement: Enteral vitamin D supplementation of 800 IU/dayParticipants will receive enteral vitamin D supplementation of 800 IU/day for 28 days |
Who may qualify
- Ages
- 28 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- neonates with gestational age 28-34 weeks
- tolerated enteral feedings more than 30ml/kg
Key exclusion criteria (4 listed)
- infants with major congenital anomaly
- infants with gastrointestinal obstruction
- infants with congenital renal failure
- infants with cholestassis
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 |
|---|---|---|
| Enteral vitamin D supplementation of 800 IU/dayHigher dose of enteral vitamin D supplementations (800 IU/day) are given for 28 days, and vitamin D status are examined before and after supplementation | Dietary supplement | 800 IU |
| Enteral vitamin D supplementation of 400 IU/dayStandard recommended dose of enteral vitamin D supplementations (400 IU/day) are given for 28 days, and vitamin D status are examined before and after supplementation | Dietary supplement | 400 IU |
Primary outcome
25(OH)D level
Time frame: From enrollment to the end of treatment at 4 weeks
serum level of 25(OH)D
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
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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.
Rosalina D Roeslani, dr, SpA(K) principal investigator
FKUI RSCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral vitamin D supplementation of 800 IU/day and Enteral vitamin D supplementation of 400 IU/day in people with Vitamin D Supplementation, run by Universitas Indonesia at 1 site in Indonesia.
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 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: enrolling by invitation, as of the sponsor's last update on 6 Nov 2024. 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 Indonesia. 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?
This study is still under way. Results are not available in the source record yet.
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?
25(OH)D level (time frame: From enrollment to the end of treatment at 4 weeks). 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 6 Nov 2024.