Vitamin D DeficiencyPhase 2/3NCT06054919
The Effect of Vitamin D3 Therapy on Vitamin D Status in Pregnant Women With Vitamin D Deficient and Insufficient
A Phase 2/3 study testing Cholecalciferol in people with Vitamin D Deficiency, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study is a randomized controlled trial which compares the effect of vitamin D3 therapy 5,000 IU daily and 50,000 IU on 25(OH)D and 1,25(OH)2D, VDBP, and 24,25(OH)2D maternal serum levels in pregnant women with vitamin D deficient and insufficient. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2021to 30 Nov 2023
- Phase
- Phase 2/3
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pregnant women with gestational age of ≤ 14 weeks
- vitamin D deficient or insufficient (25(OH)D <30 ng/ml]
- positive fetal heart rate from ultrasound examination.
Who cannot join
- multiple pregnancy
- pregnancy with congenital anomaly
- hyperemesis gravidarum, diarrhea
- complicated medical history (hypertension, diabetes mellitus, heart, kidney, or liver disease)
- use of any dietary supplement containing vitamin D prior to enrolment
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo National Center General Hospital
Jakarta Pusat, DKI Jakarta, 13730
About this study
Official title: The Effect of Vitamin D3 Therapy on 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D Maternal Serum Levels in Pregnant Women With Vitamin D Deficient and Insufficient
This study is a randomized controlled trial which compares the effect of vitamin D3 therapy 5,000 IU daily and 50,000 IU on 25(OH)D and 1,25(OH)2D, VDBP, and 24,25(OH)2D maternal serum levels in pregnant women with vitamin D deficient and insufficient.
Read the detailed description
This is a randomized controlled trial of vitamin D therapy of 5,000 IU daily or 50,000 IU weekly during pregnancy. The study is conducted at Cipto Mangunkusumo National Center General Hospital and Koja Distict Hospital in Jakarta, Indonesia from April 2021 - December 2023. All the pregnant women are screened for eligibility when they presented to the clinic for antenatal care visits and are offered enrolment if they meet the following inclusion criteria: gestational age of ≤ 14 weeks, vitamin D deficient or insufficient (25(OH)D <30 ng/ml], and positive fetal heart rate from ultrasound examination.
Participants are randomly assigned to one of two parallel intervention groups, with allocation concealment: vitamin D3 (cholecalciferol) 5,000 IU/week or 50,000 IU/week. All participants are given a standard prenatal multivitamin. A medical history, physical, and ultrasound examination are performed. Participants complete a questionnaire about sunlight exposure. Interventions in both groups are given for four weeks. Baseline blood tests, including serum 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D are performed at recruitment. After four weeks of interventions, the maternal venous blood is collected to assess serum 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D.
- Conditions
- Vitamin D Deficiency
- Being tested
- Cholecalciferol
- 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.
CholecalciferolDrug
Also called vitamin D
vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| 50,000 IU | Experimental | Vitamin D3 50,000 IU weekly a standard prenatal multivitamin (fumarate Fe 90 mg; folic acid 0.4 mg; vitamin B6 3 mg; vitamin B12 5 mcg; sulphate cupric 0.35 mg, sulphate cobalt 0.15 mg, sulphate mangan 5 mcg, vitamin C 60 mg, vitamin E 5 mg, and phosphate calcium 60 mg) Receives: Drug: Cholecalciferol |
| 5,000 IU | Active comparator | Vitamin D3 5,000 IU daily a standard prenatal multivitamin (fumarate Fe 90 mg; folic acid 0.4 mg; vitamin B6 3 mg; vitamin B12 5 mcg; sulphate cupric 0.35 mg, sulphate cobalt 0.15 mg, sulphate mangan 5 mcg, vitamin C 60 mg, vitamin E 5 mg, and phosphate calcium 60 mg) Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH)D maternal serum level
quantified by direct competitive Chemilumiscence Immunoassay (CLIA) using LIAISON®.
Measured: 4 weeks after intervention
1,25(OH)2D maternal serum level
quantified by Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS) using ImmuTube®.
Measured: 4 weeks after intervention
VDBP maternal serum level
quantified by Enzyme-Linked Immunosorbent Assay (ELISA) using Quantikine®
Measured: 4 weeks after intervention
24,25(OH)2D maternal serum level
quantified by Acquity I Class Binary Solvent Manager FTN , Xevo TQXS Tandem Mass Spectrometry (Waters Corporation)
Measured: 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Apr 2021
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rima Irwinda, Universitas Indonesia
- Investigators
- Rima Irwinda, MD, PhD, Study chair, Departement of Obstetrics and Gynecology, Faculty of Medicine University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054919
- Sponsor's protocol ID
- 257/UN.2F1/ETIK/PPM.00.02/2023
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings
Publications
Syafitri I, Irwinda R, Saroyo YB, Purwosunu Y, Wibowo N. Maternal concentrations of vitamin D metabolites in response to high-dose oral vitamin D during first trimester pregnancy: a randomized controlled trial. BMC Nutr. 2025 Jul 4;11(1):117. doi: 10.1186/s40795-025-01104-3.
PubMed 40616177
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D3 Therapy on 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D Maternal Serum Levels in Pregnant Women With Vitamin D Deficient and Insufficient
- ClinicalTrials.gov ID
- NCT06054919
- Acronym / sponsor ID
- 257/UN.2F1/ETIK/PPM.00.02/2023
- Conditions
- Vitamin D Deficiency
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 26 Sep 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.
This study is a randomized controlled trial which compares the effect of vitamin D3 therapy 5,000 IU daily and 50,000 IU on 25(OH)D and 1,25(OH)2D, VDBP, and 24,25(OH)2D maternal serum levels in pregnant women with vitamin D deficient and insufficient.
Detailed description
This is a randomized controlled trial of vitamin D therapy of 5,000 IU daily or 50,000 IU weekly during pregnancy. The study is conducted at Cipto Mangunkusumo National Center General Hospital and Koja Distict Hospital in Jakarta, Indonesia from April 2021 - December 2023. All the pregnant women are screened for eligibility when they presented to the clinic for antenatal care visits and are offered enrolment if they meet the following inclusion criteria: gestational age of ≤ 14 weeks, vitamin D deficient or insufficient (25(OH)D <30 ng/ml], and positive fetal heart rate from ultrasound examination.
Participants are randomly assigned to one of two parallel intervention groups, with allocation concealment: vitamin D3 (cholecalciferol) 5,000 IU/week or 50,000 IU/week. All participants are given a standard prenatal multivitamin. A medical history, physical, and ultrasound examination are performed. Participants complete a questionnaire about sunlight exposure. Interventions in both groups are given for four weeks. Baseline blood tests, including serum 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D are performed at recruitment. After four weeks of interventions, the maternal venous blood is collected to assess serum 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50,000 IU | Experimental | Drug: CholecalciferolVitamin D3 50,000 IU weekly a standard prenatal multivitamin (fumarate Fe 90 mg; folic acid 0.4 mg; vitamin B6 3 mg; vitamin B12 5 mcg; sulphate cupric 0.35 mg, sulphate cobalt 0.15 mg, sulphate mangan 5 mcg, vitamin C 60 mg, vitamin E 5 mg, and phosphate calcium 60 mg) |
| 5,000 IU | Active comparator | Drug: CholecalciferolVitamin D3 5,000 IU daily a standard prenatal multivitamin (fumarate Fe 90 mg; folic acid 0.4 mg; vitamin B6 3 mg; vitamin B12 5 mcg; sulphate cupric 0.35 mg, sulphate cobalt 0.15 mg, sulphate mangan 5 mcg, vitamin C 60 mg, vitamin E 5 mg, and phosphate calcium 60 mg) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- pregnant women with gestational age of ≤ 14 weeks
- vitamin D deficient or insufficient (25(OH)D <30 ng/ml]
- positive fetal heart rate from ultrasound examination.
Key exclusion criteria (5 listed)
- multiple pregnancy
- pregnancy with congenital anomaly
- hyperemesis gravidarum, diarrhea
- complicated medical history (hypertension, diabetes mellitus, heart, kidney, or liver disease)
- use of any dietary supplement containing vitamin D prior to enrolment
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 |
|---|---|---|
| CholecalciferolAlso: vitamin Dvitamin D3 | Drug | 5,000 IU, 50,000 IU |
Primary outcome
25(OH)D maternal serum level
Time frame: 4 weeks after intervention
quantified by direct competitive Chemilumiscence Immunoassay (CLIA) using LIAISON®.
1,25(OH)2D maternal serum level
Time frame: 4 weeks after intervention
quantified by Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS) using ImmuTube®.
VDBP maternal serum level
Time frame: 4 weeks after intervention
quantified by Enzyme-Linked Immunosorbent Assay (ELISA) using Quantikine®
24,25(OH)2D maternal serum level
Time frame: 4 weeks after intervention
quantified by Acquity I Class Binary Solvent Manager FTN , Xevo TQXS Tandem Mass Spectrometry (Waters Corporation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 40616177Syafitri I, Irwinda R, Saroyo YB, Purwosunu Y, Wibowo N. Maternal concentrations of vitamin D metabolites in response to high-dose oral vitamin D during first trimester pregnancy: a randomized controlled trial. BMC Nutr. 2025 Jul 4;11(1):117. doi: 10.1186/s40795-025-01104-3.
- Individual participant dataSharing planned: Yes. The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings
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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.
Rima Irwinda, MD, PhD study chair
Departement of Obstetrics and Gynecology, Faculty of Medicine University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cholecalciferol in people with Vitamin D Deficiency, 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 3 inclusion and 5 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 Sep 2023. 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.
What does this combined 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.
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?
Results are not available in the source record.
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 maternal serum level (time frame: 4 weeks after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06054919, which also lists 1 linked publication.
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 Sep 2023.