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Trial of Vitamin D Supplements to Raise Calcidiol Levels of Pregnant Women in Mongolia

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ClinicalTrials.gov Identifier: NCT02395081
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : January 19, 2017
Sponsor:
Collaborators:
National Center for Maternal and Child Health Research, Mongolia
Zuun Kharaa Hospital
Information provided by (Responsible Party):
Janet Rich-Edwards, Brigham and Women's Hospital

Brief 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 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.

Condition or disease Intervention/treatment Phase
Pregnancy Vitamin D Deficiency Dietary Supplement: 600 IU Vitamin D3 in prenatal vitamin Dietary Supplement: 2000 IU Vitamin D3 in prenatal vitamin Dietary Supplement: 4000 IU Vitamin D3 in prenatal vitamin Not Applicable

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 DSMB and IRBs 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trial of Vitamin D Supplements to Raise Calcidiol Levels of Pregnant Women in Mongolia
Study Start Date : February 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Placebo Comparator: 600 IU
Women will receive prenatal vitamins containing 600 IU of Vitamin D.
Dietary Supplement: 600 IU Vitamin D3 in prenatal vitamin
Women will receive 600 IU 25(OH)D in prenatal vitamin.

Experimental: 2000 IU
Women will receive prenatal vitamins containing 2000 IU of Vitamin D.
Dietary Supplement: 2000 IU Vitamin D3 in prenatal vitamin
Women will receive 2000 IU 25(OH)D in prenatal vitamin.

Experimental: 4000 IU
Women will receive prenatal vitamins containing 4000 IU of Vitamin D.
Dietary Supplement: 4000 IU Vitamin D3 in prenatal vitamin
Women will receive 4000 IU 25(OH)D in prenatal vitamin.




Primary Outcome Measures :
  1. Circulating 25(OH)D serum levels as measured by DiaSorin assay [ Time Frame: 36 weeks gestation or delivery ]
    Circulating vitamin D levels at end of the study


Secondary Outcome Measures :
  1. Preeclampsia prevalence as measured by new onset hypertension after 20 weeks gestation and proteinuria [ Time Frame: During pregnancy ]
    Investigators will assess incidence of preeclampsia by study arm.

  2. Average monthly change in blood pressure as measured by automated Omron blood pressure cuff [ Time Frame: During pregnancy ]
    Investigators will assess blood pressure by study arm.

  3. Arterial tonometry as measured by AtCor Medical SphygmoCor device [ Time Frame: 36 weeks gestation ]
    Investigators will assess AIx and PWV by study arm.

  4. Preterm delivery as measured by clinical diagnosis [ Time Frame: During pregnancy ]
    Investigators will assess incidence of preterm delivery by study arm.

  5. Caesarean section as measured by medical record abstraction [ Time Frame: Delivery ]
    Investigators will assess incidence of caesarean section by study arm.

  6. Assisted vaginal delivery as measured by medical record abstraction [ Time Frame: Delivery ]
    Investigators will assess incidence of assisted vaginal delivery by study arm.

  7. Small for gestational age neonate as measured by medical record abstraction [ Time Frame: Delivery ]
    Investigators will assess incidence of small for gestational age neonate by study arm.

  8. Large for gestational age neonate as measured by medical record abstraction [ Time Frame: Delivery ]
    Investigators will assess incidence of large for gestational age neonate by study arm.

  9. Calcemia as measured by serum calcium test [ Time Frame: 2 months after randomization and 36-40 weeks of pregnancy/delivery ]
    Investigators will assess blood calcium levels twice during pregnancy.

  10. Proteinuria as measured by urine dipstick [ Time Frame: 36-40 weeks gestation/delivery ]
    Investigators will assess urine protein levels by dipstick at the end of pregnancy

  11. Hypertensive disorders of pregnancy prevalence as measured by clinical diagnosis [ Time Frame: During pregnancy ]
    Investigators will measure the prevalence of hypertensive disorders of pregnancy.

  12. Bacterial vaginosis as measured by KOH wet mount [ Time Frame: During pregnancy ]
    Investigators will measure the prevalence of bacterial vaginosis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395081


Locations
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Mongolia
Zuun Kharaa Hospital
Zuun Kharaa, Selenge Aimag, Mongolia
Sponsors and Collaborators
Brigham and Women's Hospital
National Center for Maternal and Child Health Research, Mongolia
Zuun Kharaa Hospital
Investigators
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Principal Investigator: Janet Rich-Edwards, ScD Brigham and Women's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janet Rich-Edwards, Director of Developmental Epidemiology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02395081     History of Changes
Other Study ID Numbers: 14-0591-02
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017

Keywords provided by Janet Rich-Edwards, Brigham and Women's Hospital:
pregnancy
Mongolia
Vitamin D
preeclampsia

Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcifediol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents