Prevention of Adverse Pregnancy Outcome With Vitamin D Supplementation During Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Dow University of Health Sciences.
Recruitment status was  Active, not recruiting
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
  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 ]

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 April 23, 2014