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Completed

NCT Number: NCT03101150

Effect of Vitamin D3 Supplementation in Pregnancy 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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

400 IU Vitamin D3

Drug

Antenatal multivitamin

Other names: Materna

4000 IU Vitamin D3

Drug

4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily

Other names: Vidrop

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

King Fahad Medical City

Other Gov

Registry information

Official study title

Effect of Antenatal Vitamin D3 Supplementation on Risk of Pre-eclampsia

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 4, 2017
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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