Vitamin D DeficiencyPhase 1/2NCT03101150
Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia
A Phase 1/2 study testing 400 IU Vitamin D3 and 4000 IU Vitamin D3 in people with Vitamin D Deficiency and Pre-Eclampsia, run by King Fahad Medical City.
Trial summary
Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia cases. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Pre-Eclampsia
- What is being tested?
- 400 IU Vitamin D3 and 4000 IU Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2012to 31 Dec 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Confirmed singleton pregnancy of less than 13 completed weeks of gestation at the time of consent.
- Planned to receive antenatal care in King Fahad Medical City antenatal clinic.
- The ability to provide written informed consent at the first visit.
- Low risk pregnancy; and Serum vitamin D3 levels less than < 25nmol/L.
Who cannot join
- Mothers with pregnancy with abnormal foetus.
- Previous history of hypertension, pre-eclampsia, recurrent miscarriages.
- Chronic kidney disease, chronic liver disease, and malignancy.
About this study
Official title: Effect of Antenatal Vitamin D3 Supplementation on Risk of Pre-eclampsia
Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia cases.
Read the detailed description
Vitamin D3 has key role in decidualization and implantation of placenta.Vitamin D deficiency is thought to have positive association with pre-eclampsia.Vitamin D deficiency is highly prevalent in some parts of the world and it is not universally screened antenatally. Pre-eclampsia is a known multifactorial pregnancy disorder with significant maternal and perinatal morbidity and mortality. Vitamin D3 has a down-regulating effect on inflammatory pathways and reducing endothelial cell damage.
Investigators want to assess in vitamin D deficient group whether treatment reduces the risk of pre-eclampsia.
- Conditions
- Vitamin D Deficiency, Pre-Eclampsia
- Being tested
- 400 IU Vitamin D3, 4000 IU Vitamin D3
- Keywords
- Maternal vitamin D, Deficiency, Insufficiency, Pregnancy, Pre-eclampsia, IUGR
- Medical subject headings
- Vitamin D Deficiency, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 IU Vitamin D3Drug
Also called Materna
Antenatal multivitamin
4000 IU Vitamin D3Drug
Also called Vidrop
4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily
| Study group | Role | What they receive |
|---|---|---|
| 400 IU Vitamin D3 | Active comparator | 400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery. Receives: Drug: 400 IU Vitamin D3 |
| 4000 IU Vitamin D3 | Experimental | 4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery. Receives: Drug: 4000 IU Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Pre-eclampsia in Both Arms
Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose.
Measured: From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks.
Secondary outcomes (2)
Change in Vitamin D Level
Level of Improvement in Vitamin D status in both arms
Measured: At 36th week of pregnancy
Number of Patients With Intrauterine Growth Retardation
Patients having fetus with retardation of growth in both arms.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Oct 2012
- Primary completion31 Oct 2014
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Fahad Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aisha Mansoor Ali, King Fahad Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101150
- Sponsor's protocol ID
- IRB00008644
- Status last verified
- Feb 2018
- First submitted
- 21 Mar 2017
- Last updated
- 2 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antenatal Vitamin D3 Supplementation on Risk of Pre-eclampsia
- ClinicalTrials.gov ID
- NCT03101150
- Acronym / sponsor ID
- IRB00008644
- Conditions
- Vitamin D Deficiency, Pre-Eclampsia
- Keywords
- Maternal vitamin D, Deficiency, Insufficiency, Pregnancy, Pre-eclampsia, IUGR
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 31 Oct 2014 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia cases.
Detailed description
Vitamin D3 has key role in decidualization and implantation of placenta.Vitamin D deficiency is thought to have positive association with pre-eclampsia.Vitamin D deficiency is highly prevalent in some parts of the world and it is not universally screened antenatally. Pre-eclampsia is a known multifactorial pregnancy disorder with significant maternal and perinatal morbidity and mortality. Vitamin D3 has a down-regulating effect on inflammatory pathways and reducing endothelial cell damage.
Investigators want to assess in vitamin D deficient group whether treatment reduces the risk of pre-eclampsia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 400 IU Vitamin D3 | Active comparator | Drug: 400 IU Vitamin D3400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery. |
| 4000 IU Vitamin D3 | Experimental | Drug: 4000 IU Vitamin D34000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Confirmed singleton pregnancy of less than 13 completed weeks of gestation at the time of consent.
- Planned to receive antenatal care in King Fahad Medical City antenatal clinic.
- The ability to provide written informed consent at the first visit.
- Low risk pregnancy; and Serum vitamin D3 levels less than < 25nmol/L.
Key exclusion criteria (3 listed)
- Mothers with pregnancy with abnormal foetus.
- Previous history of hypertension, pre-eclampsia, recurrent miscarriages.
- Chronic kidney disease, chronic liver disease, and malignancy.
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 |
|---|---|---|
| 400 IU Vitamin D3Also: MaternaAntenatal multivitamin | Drug | 400 IU Vitamin D3 |
| 4000 IU Vitamin D3Also: Vidrop4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily | Drug | 4000 IU Vitamin D3 |
Primary outcome
Number of Participants With Pre-eclampsia in Both Arms
Time frame: From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks.
Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose.
2 secondary outcomes
Change in Vitamin D Level
Time frame: At 36th week of pregnancy
Number of Patients With Intrauterine Growth Retardation
Time frame: At delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 400 IU Vitamin D3 and 4000 IU Vitamin D3 in people with Vitamin D Deficiency and Pre-Eclampsia, run by King Fahad Medical City.
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 4 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: finished, as of the sponsor's last update on 2 Nov 2018. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Pre-eclampsia in Both Arms (time frame: From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 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 2 Nov 2018.