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
|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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- 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.
- Change in Vitamin D Level [ Time Frame: At 36th week of pregnancy ]Level of Improvement in Vitamin D status in both arms
- Number of Patients With Intrauterine Growth Retardation [ Time Frame: At delivery ]Patients having fetus with retardation of growth in both arms.