search
Back to results

Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia

Primary Purpose

Vitamin D Deficiency, Pre-Eclampsia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
400 IU Vitamin D3
4000 IU Vitamin D3
Sponsored by
King Fahad Medical City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring Maternal vitamin D, Deficiency, Insufficiency, Pregnancy, Pre-eclampsia, IUGR

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Mothers with pregnancy with abnormal foetus.
  • Previous history of hypertension, pre-eclampsia, recurrent miscarriages.
  • Chronic kidney disease, chronic liver disease, and malignancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    400 IU Vitamin D3

    4000 IU Vitamin D3

    Arm Description

    400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery.

    4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery.

    Outcomes

    Primary Outcome Measures

    Number of Participants With Pre-eclampsia in Both Arms
    Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose.

    Secondary Outcome Measures

    Change in Vitamin D Level
    Level of Improvement in Vitamin D status in both arms
    Number of Patients With Intrauterine Growth Retardation
    Patients having fetus with retardation of growth in both arms.

    Full Information

    First Posted
    March 21, 2017
    Last Updated
    February 24, 2018
    Sponsor
    King Fahad Medical City
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03101150
    Brief Title
    Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia
    Official Title
    Effect of Antenatal Vitamin D3 Supplementation on Risk of Pre-eclampsia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2012 (Actual)
    Primary Completion Date
    October 31, 2014 (Actual)
    Study Completion Date
    December 31, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Fahad Medical City

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin D Deficiency, Pre-Eclampsia
    Keywords
    Maternal vitamin D, Deficiency, Insufficiency, Pregnancy, Pre-eclampsia, IUGR

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    179 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    400 IU Vitamin D3
    Arm Type
    Active Comparator
    Arm Description
    400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery.
    Arm Title
    4000 IU Vitamin D3
    Arm Type
    Experimental
    Arm Description
    4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery.
    Intervention Type
    Drug
    Intervention Name(s)
    400 IU Vitamin D3
    Other Intervention Name(s)
    Materna
    Intervention Description
    Antenatal multivitamin
    Intervention Type
    Drug
    Intervention Name(s)
    4000 IU Vitamin D3
    Other Intervention Name(s)
    Vidrop
    Intervention Description
    4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily
    Primary Outcome Measure Information:
    Title
    Number of Participants With Pre-eclampsia in Both Arms
    Description
    Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose.
    Time Frame
    From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks.
    Secondary Outcome Measure Information:
    Title
    Change in Vitamin D Level
    Description
    Level of Improvement in Vitamin D status in both arms
    Time Frame
    At 36th week of pregnancy
    Title
    Number of Patients With Intrauterine Growth Retardation
    Description
    Patients having fetus with retardation of growth in both arms.
    Time Frame
    At delivery

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Pregnant population
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Mothers with pregnancy with abnormal foetus. Previous history of hypertension, pre-eclampsia, recurrent miscarriages. Chronic kidney disease, chronic liver disease, and malignancy.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia

    We'll reach out to this number within 24 hrs