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Prevention of Adverse Pregnancy Outcome With Vitamin D Supplementation During Pregnancy

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ClinicalTrials.gov Identifier: NCT01418664
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : April 25, 2016
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Nazli Hossain, Dow University of Health Sciences

Brief Summary:
We hypothesized that vitamin D supplementation during pregnancy can prevent adverse pregnancy outcome.

Condition or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: D Max drops Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Adverse Pregnancy Outcome With Vitamin D Supplementation During Pregnancy
Study Start Date : September 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Study group
Each woman in above group will recieve in addition to routine ferrous sulphate and calcium lactate, 4000IU of vitamin D
Dietary Supplement: D Max drops
Women in study arm will be cases, and will recieve ferrous sulphate and calcium lactate, along with 4000IU D Max drops
No Intervention: control group
Women in this group will recieve ferrous sulphate and calcium lactate



Primary Outcome Measures :
  1. Prevention of adverse pregnancy outcome, viz preeclampsia, small for gestational age (SGA), preterm labor [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Cord levels and maternal serum levels of 1,25(OH), after supplementation at the time of delivery. [ Time Frame: 18 months ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women attending antenatal clinic at ≤ 20 weeks of gestation
  • Normoglycemic, normotensive at the time of antenatal booking

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418664


Locations
Pakistan
Dow University of Health Sciences
Karachi, Sindh, Pakistan, 74200
Sponsors and Collaborators
Dow University of Health Sciences
Yale University
Investigators
Principal Investigator: Nazli Hossain, MBBS, FCPS Dow University of Health Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nazli Hossain, associate professor, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT01418664     History of Changes
Other Study ID Numbers: 786
other Grant ( Other Grant/Funding Number: Pakistan Medical Research Council )
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data has been published

Keywords provided by Nazli Hossain, Dow University of Health Sciences:
vitamin D
adverse pregnancy outcome
Pakistan

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents