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Prevention of Adverse Pregnancy Outcome With Vitamin D Supplementation During Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Nazli Hossain, Dow University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01418664
First received: August 15, 2011
Last updated: April 21, 2016
Last verified: April 2016
  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:


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 ]

Enrollment: 172
Study Start Date: September 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (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
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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 
Study First Received: August 15, 2011
Last Updated: April 21, 2016
Health Authority: Pakistan: Research Ethics Committee
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Data has been published

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016