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Prevention of Adverse Pregnancy Outcome With Vitamin D Supplementation During Pregnancy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Yale University
Information provided by:
Dow University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01418664
First received: August 15, 2011
Last updated: August 16, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention
Pregnancy
 Dietary Supplement: D Max drops

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Adverse Pregnancy Outcome With Vitamin D Supplementation During Pregnancy

Resource links provided by NLM:

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

Further study details as provided by Dow University of Health Sciences:

Primary Outcome Measures:
  • Prevention of adverse pregnancy outcome, viz preeclampsia, small for gestational age (SGA), preterm labor [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cord levels and maternal serum levels of 1,25(OH), after supplementation at the time of delivery. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: March 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: D Max drops
No Intervention: control group
Women in this group will recieve ferrous sulphate and calcium lactate

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 15, 2011
Last Updated: August 16, 2011
Health Authority: Pakistan: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on June 17, 2013