Prevention of Adverse Pregnancy Outcome With Vitamin D Supplementation During Pregnancy
2 other identifiers
interventional
172
1 country
1
Brief Summary
We hypothesized that vitamin D supplementation during pregnancy can prevent adverse pregnancy outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pregnancy
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 15, 2011
CompletedFirst Posted
Study publicly available on registry
August 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedApril 25, 2016
April 1, 2016
1.7 years
August 15, 2011
April 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevention of adverse pregnancy outcome, viz preeclampsia, small for gestational age (SGA), preterm labor
18 months
Secondary Outcomes (1)
Cord levels and maternal serum levels of 1,25(OH), after supplementation at the time of delivery.
18 months
Study Arms (2)
Study group
ACTIVE COMPARATOREach woman in above group will recieve in addition to routine ferrous sulphate and calcium lactate, 4000IU of vitamin D
control group
NO INTERVENTIONWomen in this group will recieve ferrous sulphate and calcium lactate
Interventions
Women in study arm will be cases, and will recieve ferrous sulphate and calcium lactate, along with 4000IU D Max drops
Eligibility Criteria
You may qualify if:
- Pregnant women attending antenatal clinic at ≤ 20 weeks of gestation
- Normoglycemic, normotensive at the time of antenatal booking
You may not qualify if:
- Multiple pregnancy
- H/O hypertensive disorders in previous pregnancy
- Known diabetic or h/o gestational diabetes in previous pregnancy
- H/O endocrine disorders ( thyroid, parathyroid dysfunction)
- Chronic renal diseases
- Tuberculosis
- Breast feeding (current)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dow University of Health Scienceslead
- Yale Universitycollaborator
Study Sites (1)
Dow University of Health Sciences
Karachi, Sindh, 74200, Pakistan
Related Publications (2)
Finkelstein JL, Cuthbert A, Weeks J, Venkatramanan S, Larvie DY, De-Regil LM, Garcia-Casal MN. Daily oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2024 Aug 15;8(8):CD004736. doi: 10.1002/14651858.CD004736.pub6.
PMID: 39145520DERIVEDHossain N, Kanani FH, Ramzan S, Kausar R, Ayaz S, Khanani R, Pal L. Obstetric and neonatal outcomes of maternal vitamin D supplementation: results of an open-label, randomized controlled trial of antenatal vitamin D supplementation in Pakistani women. J Clin Endocrinol Metab. 2014 Jul;99(7):2448-55. doi: 10.1210/jc.2013-3491. Epub 2014 Mar 19.
PMID: 24646102DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Nazli Hossain, MBBS, FCPS
Dow University of Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
August 15, 2011
First Posted
August 17, 2011
Study Start
September 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
April 25, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will share
Data has been published