PregnancyNCT02395081
Trial of Vitamin D Supplements to Raise Calcidiol Levels of Pregnant Women in Mongolia
A study testing 600 IU Vitamin D3 in prenatal vitamin, 2000 IU Vitamin D3 in prenatal vitamin and 4000 IU Vitamin D3 in prenatal vitamin in people with Pregnancy and Vitamin D Deficiency, run by Brigham and Women's Hospital at 1 site in Mongolia.
Trial summary
A double-blind randomized, placebo-controlled trial comparing the impact of 600 IU, 2000 IU, or 4000 IU of Vitamin D3 on third trimester 25(OH)D levels and change from baseline. The Vitamin D will be integrated in a standard prenatal vitamin, which will be taken from 12-16 weeks' gestation and continue throughout… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Vitamin D Deficiency
- What is being tested?
- 600 IU Vitamin D3 in prenatal vitamin, 2000 IU Vitamin D3 in prenatal vitamin and 4000 IU Vitamin D3 in prenatal vitamin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteMongolia
- Study dates
- Feb 2015to Dec 2016
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- 12-16 weeks pregnant
- Receiving prenatal care at Zuun Kharaa Hospital and planning to deliver at Zuun Kharaa Hospital
- Willing not to take any additional vitamin D supplements, other than the study dispensed pills
Who cannot join
- Existing known seizure disorder, renal failure, parathyroid disease, thyroid disease, sarcoidosis, cancer, or tuberculosis. (Tuberculosis is routinely screened in pregnancy)
- History of kidney stones
- Known sensitivity to multivitamin preparations
- Taking vitamin D supplements containing >600 IU/day.
Trial locations and contacts
1 site in 1 country.
About this study
A double-blind randomized, placebo-controlled trial comparing the impact of 600 IU, 2000 IU, or 4000 IU of Vitamin D3 on third trimester 25(OH)D levels and change from baseline. The Vitamin D will be integrated in a standard prenatal vitamin, which will be taken from 12-16 weeks' gestation and continue throughout pregnancy. Umbilical cord 25(OH)D levels will also be determined. The investigators will generate preliminary data regarding Vitamin D intake and hypertensive disorders, blood pressure, and arterial function measured by tonography. The investigators will independently test blood pressure and proteinuria to identify preeclampsia cases.
Read the detailed description
Vitamin D deficiency (serum 25(OH)D levels <20 ng/ml or 50 nmol/l) is widespread among Mongolians and is nearly universal during the winter months. The investigators have conducted a series of studies which have shown nearly universal Vitamin D deficiency in the winter months.
Observational studies in the U.S. have linked low 25(OH)D levels in women to a higher risk of preeclampsia. Mongolians also report levels of preeclampsia that are 3 times higher than those in the U.S (official reports cite 15%, though this may include gestational hypertension).
Given the widespread Vitamin D deficiency in Mongolian women, the high prevalence of hypertensive pregnancy in Mongolia, and the observational studies linking low 25(OH)D levels with preeclampsia risk, the investigators are conducting a pilot Vitamin D dosing trial to:
- Determine what level of Vitamin D supplementation is needed to secure 25(OH)D levels of at least 20 ng/ml in pregnant Mongolian women
- Generate preliminary data in support of a funding application for a larger trial of Vitamin D supplements to prevent preeclampsia in Mongolia
A double-blind randomized, placebo-controlled trial comparing the impact of 600 IU, 2000 IU, or 4000 IU of Vitamin D3 on third trimester 25(OH)D levels and change from baseline. The Vitamin D will be integrated in a standard prenatal vitamin, which will be taken from 12-16 weeks' gestation and continue throughout pregnancy. Umbilical cord 25(OH)D levels will also be determined. The investigators will generate preliminary data regarding Vitamin D intake and hypertensive disorders, blood pressure, and arterial function measured by tonography. The investigators will independently test blood pressure and proteinuria to identify preeclampsia cases.
The investigators will enroll 360 women who plan to receive their prenatal care and deliver at Zuun Kharaa Hospital in the Selenge province in northern Mongolia. Enrollment will be stratified by season. 120 women will be randomized to each of the three doses of vitamin D (600, 2000, 4000 IU) included in a standard prenatal vitamin.
Calcemia will be monitored two months after randomization and weeks 36-40 of pregnancy. Adverse events of pregnancy will be reported to the Data Safety and Monitoring Board (DSMB) and Institutional Review Board (IRB) per protocol.
Data will be gathered by a Mongolian study coordinator and local clinicians. A DSMB comprised of a U.S. and Mongolian clinicians and statisticians will monitor study data for safety.
- Conditions
- Pregnancy, Vitamin D Deficiency
- Being tested
- 600 IU Vitamin D3 in prenatal vitamin, 2000 IU Vitamin D3 in prenatal vitamin, 4000 IU Vitamin D3 in prenatal vitamin
- Keywords
- pregnancy, Mongolia, Vitamin D, preeclampsia
- 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.
600 IU Vitamin D3 in prenatal vitaminDietary supplement
Women will receive 600 IU 25(OH)D in prenatal vitamin.
2000 IU Vitamin D3 in prenatal vitaminDietary supplement
Women will receive 2000 IU 25(OH)D in prenatal vitamin.
4000 IU Vitamin D3 in prenatal vitaminDietary supplement
Women will receive 4000 IU 25(OH)D in prenatal vitamin.
| Study group | Role | What they receive |
|---|---|---|
| 600 IU | Placebo comparator | Women will receive prenatal vitamins containing 600 IU of Vitamin D. Receives: Dietary Supplement: 600 IU Vitamin D3 in prenatal vitamin |
| 2000 IU | Experimental | Women will receive prenatal vitamins containing 2000 IU of Vitamin D. Receives: Dietary Supplement: 2000 IU Vitamin D3 in prenatal vitamin |
| 4000 IU | Experimental | Women will receive prenatal vitamins containing 4000 IU of Vitamin D. Receives: Dietary Supplement: 4000 IU Vitamin D3 in prenatal vitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Serum 25(OH)D Concentration
Circulating vitamin D at the end of the study as measured by VIDAS® enzyme linked fluorescent assay (ELFA)
Measured: 36 weeks gestation or delivery, if delivery occurred before 36 weeks
Secondary outcomes (13)
The Number of Participants With Preeclampsia
Preeclampsia as measured by new onset hypertension after 20 weeks gestation and proteinuria.
Measured: After 20 weeks gestation
Average Monthly Blood Pressure
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) were measured in mm Hg at each antenatal care visit by the Study Coordinator, using the Omron- Elite 7300 (Omron Healthcare, Bannockburn, Illinois, USA) automated blood pressure monitor. Three blood pressure readings were taken after at least five minutes seated rest. For the analysis of mean blood pressures at each antenatal visit, the three readings were averaged for each participant.
Measured: During pregnancy
Arterial Tonometry
Investigators will assess Augmentation Index (AIx) and Pulse Wave Velocity (PWV) by study arm, as measured by AtCor Medical SphygmoCor device. THIS TONOMETER FAILED AND COULD NOT BE REPAIRED, SO WE ARE NOT PRESENTING THESE DATA AS OUTCOMES.
Measured: 36 weeks gestation
Number of Patients With Preterm Delivery as Measured by Clinical Diagnosis
Gestational age was determined clinically by last menstrual period and by routine first trimester ultrasound which was universal; where these differed by more than 10 days, the ultrasound date was used. Gestational age at delivery was recorded by clinicians and rounded to the nearest week. Preterm delivery was defined as delivery before the 37th week of gestation.
Measured: During pregnancy
Casarean Section as Measured by Medical Record Abstraction
Cesarean section was abstracted from the labor and delivery chart.
Measured: Delivery
Assisted Vaginal Delivery as Measured by Medical Record Abstraction
Assisted vaginal delivery with forceps delivery was abstracted from the labor and delivery chart.
Measured: Delivery
Number of Small for Gestational Age (SGA) Neonates as Measured by Medical Record Abstraction
SGA defined by the lowest 10th percentiles of sex-specific birthweight for gestational age charts of the INTERGROWTH-21st study
Measured: Delivery
Number of Large for Gestational Age (LGA) Neonates as Measured by Medical Record Abstraction
LGA defined by the highest 10th percentiles of sex-specific birthweight for gestational age charts of the INTERGROWTH-21st study
Measured: Delivery
Mean Calcemia as Measured by Serum Calcium Test (2mo)
Measured on a semi-automated photometer (Humalyzer 3500, Human Diagnostics, Magdeburg, Germany)
Measured: 2 months after randomization
Number of Patients With Proteinuria as Measured by Urine Dipstick
Proteinuria at last antenatal visit (usually 36-40 weeks' gestation), measured by 1+ Standard Diagnostics UroColor 10 10 (Kyonggi-do, South Korea) reagent strips
Measured: 36-40 weeks gestation/delivery
Number of Patients With Hypertensive Disorders of Pregnancy as Measured by Clinical Diagnosis
In Mongolia, clinician-diagnosed preeclampsia may include a blood pressure increases >30 mm Hg above early pregnancy, with or without documented hypertension, proteinuria, or symptoms such as headache and edema
Measured: During pregnancy
Number of Patients With Bacterial Vaginosis as Measured by Potassium Hydroxide (KOH) Wet Mount
Bacterial vaginosis was routinely screened by potassium hydroxide wet mount at the first antenatal visit, at 28 weeks' and 32 weeks' gestation. It was also diagnosed by whiff test. We included both wet mount and whiff test positive in the bacterial vaginosis endpoint
Measured: During pregnancy
Mean Calcemia as Measured by Serum Calcium Test (36-40 Weeks)
Measured on a semi-automated photometer (Humalyzer 3500, Human Diagnostics, Magdeburg, Germany)
Measured: 36-40 weeks of pregnancy/delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2016
- Study completionDec 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Maternal and Child Health, Mongolia, Zuun Kharaa Hospital
- Responsible party
- Principal investigator, Janet Rich-Edwards, Brigham and Women's Hospital
- Investigators
- Janet Rich-Edwards, ScD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395081
- Sponsor's protocol ID
- 14-0591-02
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2015
- Last updated
- 23 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Enkhmaa D, Tanz L, Ganmaa D, Enkhtur S, Oyun-Erdene B, Stuart J, Chen G, Carr A, Seely EW, Fitzmaurice G, Buyandelger Y, Sarantsetseg B, Gantsetseg G, Rich-Edwards J. Randomized trial of three doses of vitamin D to reduce deficiency in pregnant Mongolian women. EBioMedicine. 2019 Jan;39:510-519. doi: 10.1016/j.ebiom.2018.11.060. Epub 2018 Dec 11.
PubMed 30552064
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Vitamin D Supplements to Raise Calcidiol Levels of Pregnant Women in Mongolia
- ClinicalTrials.gov ID
- NCT02395081
- Acronym / sponsor ID
- 14-0591-02
- Conditions
- Pregnancy, Vitamin D Deficiency
- Keywords
- pregnancy, Mongolia, Vitamin D, preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Center for Maternal and Child Health, Mongolia, Zuun Kharaa Hospital
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Posted 23 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double-blind randomized, placebo-controlled trial comparing the impact of 600 IU, 2000 IU, or 4000 IU of Vitamin D3 on third trimester 25(OH)D levels and change from baseline. The Vitamin D will be integrated in a standard prenatal vitamin, which will be taken from 12-16 weeks' gestation and continue throughout pregnancy. Umbilical cord 25(OH)D levels will also be determined. The investigators will generate preliminary data regarding Vitamin D intake and hypertensive disorders, blood pressure, and arterial function measured by tonography. The investigators will independently test blood pressure and proteinuria to identify preeclampsia cases.
Detailed description
Vitamin D deficiency (serum 25(OH)D levels <20 ng/ml or 50 nmol/l) is widespread among Mongolians and is nearly universal during the winter months. The investigators have conducted a series of studies which have shown nearly universal Vitamin D deficiency in the winter months.
Observational studies in the U.S. have linked low 25(OH)D levels in women to a higher risk of preeclampsia. Mongolians also report levels of preeclampsia that are 3 times higher than those in the U.S (official reports cite 15%, though this may include gestational hypertension).
Given the widespread Vitamin D deficiency in Mongolian women, the high prevalence of hypertensive pregnancy in Mongolia, and the observational studies linking low 25(OH)D levels with preeclampsia risk, the investigators are conducting a pilot Vitamin D dosing trial to:
- Determine what level of Vitamin D supplementation is needed to secure 25(OH)D levels of at least 20 ng/ml in pregnant Mongolian women
- Generate preliminary data in support of a funding application for a larger trial of Vitamin D supplements to prevent preeclampsia in Mongolia
A double-blind randomized, placebo-controlled trial comparing the impact of 600 IU, 2000 IU, or 4000 IU of Vitamin D3 on third trimester 25(OH)D levels and change from baseline. The Vitamin D will be integrated in a standard prenatal vitamin, which will be taken from 12-16 weeks' gestation and continue throughout pregnancy. Umbilical cord 25(OH)D levels will also be determined. The investigators will generate preliminary data regarding Vitamin D intake and hypertensive disorders, blood pressure, and arterial function measured by tonography. The investigators will independently test blood pressure and proteinuria to identify preeclampsia cases.
The investigators will enroll 360 women who plan to receive their prenatal care and deliver at Zuun Kharaa Hospital in the Selenge province in northern Mongolia. Enrollment will be stratified by season. 120 women will be randomized to each of the three doses of vitamin D (600, 2000, 4000 IU) included in a standard prenatal vitamin.
Calcemia will be monitored two months after randomization and weeks 36-40 of pregnancy. Adverse events of pregnancy will be reported to the Data Safety and Monitoring Board (DSMB) and Institutional Review Board (IRB) per protocol.
Data will be gathered by a Mongolian study coordinator and local clinicians. A DSMB comprised of a U.S. and Mongolian clinicians and statisticians will monitor study data for safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 600 IU | Placebo comparator | Dietary Supplement: 600 IU Vitamin D3 in prenatal vitaminWomen will receive prenatal vitamins containing 600 IU of Vitamin D. |
| 2000 IU | Experimental | Dietary Supplement: 2000 IU Vitamin D3 in prenatal vitaminWomen will receive prenatal vitamins containing 2000 IU of Vitamin D. |
| 4000 IU | Experimental | Dietary Supplement: 4000 IU Vitamin D3 in prenatal vitaminWomen will receive prenatal vitamins containing 4000 IU of Vitamin D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- 12-16 weeks pregnant
- Receiving prenatal care at Zuun Kharaa Hospital and planning to deliver at Zuun Kharaa Hospital
- Willing not to take any additional vitamin D supplements, other than the study dispensed pills
Key exclusion criteria (4 listed)
- Existing known seizure disorder, renal failure, parathyroid disease, thyroid disease, sarcoidosis, cancer, or tuberculosis. (Tuberculosis is routinely screened in pregnancy)
- History of kidney stones
- Known sensitivity to multivitamin preparations
- Taking vitamin D supplements containing >600 IU/day.
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 |
|---|---|---|
| 600 IU Vitamin D3 in prenatal vitaminWomen will receive 600 IU 25(OH)D in prenatal vitamin. | Dietary supplement | 600 IU |
| 2000 IU Vitamin D3 in prenatal vitaminWomen will receive 2000 IU 25(OH)D in prenatal vitamin. | Dietary supplement | 2000 IU |
| 4000 IU Vitamin D3 in prenatal vitaminWomen will receive 4000 IU 25(OH)D in prenatal vitamin. | Dietary supplement | 4000 IU |
Primary outcome
Total Serum 25(OH)D Concentration
Time frame: 36 weeks gestation or delivery, if delivery occurred before 36 weeks
Circulating vitamin D at the end of the study as measured by VIDAS® enzyme linked fluorescent assay (ELFA)
13 secondary outcomes
The Number of Participants With Preeclampsia
Time frame: After 20 weeks gestation
Average Monthly Blood Pressure
Time frame: During pregnancy
Arterial Tonometry
Time frame: 36 weeks gestation
Number of Patients With Preterm Delivery as Measured by Clinical Diagnosis
Time frame: During pregnancy
Casarean Section as Measured by Medical Record Abstraction
Time frame: Delivery
Assisted Vaginal Delivery as Measured by Medical Record Abstraction
Time frame: Delivery
Number of Small for Gestational Age (SGA) Neonates as Measured by Medical Record Abstraction
Time frame: Delivery
Number of Large for Gestational Age (LGA) Neonates as Measured by Medical Record Abstraction
Time frame: Delivery
Mean Calcemia as Measured by Serum Calcium Test (2mo)
Time frame: 2 months after randomization
Number of Patients With Proteinuria as Measured by Urine Dipstick
Time frame: 36-40 weeks gestation/delivery
Number of Patients With Hypertensive Disorders of Pregnancy as Measured by Clinical Diagnosis
Time frame: During pregnancy
Number of Patients With Bacterial Vaginosis as Measured by Potassium Hydroxide (KOH) Wet Mount
Time frame: During pregnancy
Mean Calcemia as Measured by Serum Calcium Test (36-40 Weeks)
Time frame: 36-40 weeks of pregnancy/delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30552064Enkhmaa D, Tanz L, Ganmaa D, Enkhtur S, Oyun-Erdene B, Stuart J, Chen G, Carr A, Seely EW, Fitzmaurice G, Buyandelger Y, Sarantsetseg B, Gantsetseg G, Rich-Edwards J. Randomized trial of three doses of vitamin D to reduce deficiency in pregnant Mongolian women. EBioMedicine. 2019 Jan;39:510-519. doi: 10.1016/j.ebiom.2018.11.060. Epub 2018 Dec 11.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Janet Rich-Edwards, ScD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 600 IU Vitamin D3 in prenatal vitamin, 2000 IU Vitamin D3 in prenatal vitamin and 4000 IU Vitamin D3 in prenatal vitamin in people with Pregnancy and Vitamin D Deficiency, run by Brigham and Women's Hospital at 1 site in Mongolia.
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 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 23 Mar 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 Mongolia. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2021). 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?
Total Serum 25(OH)D Concentration (time frame: 36 weeks gestation or delivery, if delivery occurred before 36 weeks). 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 NCT02395081, 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 23 Mar 2021.