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

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ClinicalTrials.gov Identifier: NCT03101150
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Aisha Mansoor Ali, King Fahad Medical City

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Pre-Eclampsia Drug: 400 IU Vitamin D3 Drug: 4000 IU Vitamin D3 Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Antenatal Vitamin D3 Supplementation on Risk of Pre-eclampsia
Actual Study Start Date : October 1, 2012
Actual Primary Completion Date : October 31, 2014
Actual Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: 400 IU Vitamin D3
400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery.
Drug: 400 IU Vitamin D3
Antenatal multivitamin
Other Name: Materna

Experimental: 4000 IU Vitamin D3
4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery.
Drug: 4000 IU Vitamin D3
4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily
Other Name: Vidrop




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Vitamin D Level [ Time Frame: At 36th week of pregnancy ]
    Level of Improvement in Vitamin D status in both arms

  2. Number of Patients With Intrauterine Growth Retardation [ Time Frame: At delivery ]
    Patients having fetus with retardation of growth in both arms.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant population
Accepts Healthy Volunteers:   Yes
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.

Responsible Party: Aisha Mansoor Ali, Assistant Consultant Obstetric and Gynecology, King Fahad Medical City
ClinicalTrials.gov Identifier: NCT03101150     History of Changes
Other Study ID Numbers: IRB00008644
First Posted: April 4, 2017    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Aisha Mansoor Ali, King Fahad Medical City:
Maternal vitamin D
Deficiency
Insufficiency
Pregnancy
Pre-eclampsia
IUGR

Additional relevant MeSH terms:
Vitamin D Deficiency
Vitamins
Vitamin D
Eclampsia
Pre-Eclampsia
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hypertension, Pregnancy-Induced
Pregnancy Complications
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents