Vitamin D Treatment and Hypocalcemic Pregnant Women

January 19, 2014 updated by: Dr. Sima Hashemipour

Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia

  • Pregnant women in 24-26 gestational week will be recruited.Serum calcium and 25(OH)D will be evaluated and women with mild hypocalcemia (serum calcium 8-8.6 mg/dl) and 25(OH)D less than 30ng/ml will be entered to study. .
  • Excluding criteria are: gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs.
  • Participants will randomly assigned in to two groups of intervention and control groups .Randomization will be done by random number generator. Intervention group will receive weekly vitamin D3, 50,000 unit for 8 weeks plus daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit , control group will receive daily prenatal multivitamin.
  • At the time of delivery, serum calcium, 25(OH)D of mothers, maternal weight gain during study , Serum calcium and 25(OH)D of newborns and neonatal growth indices ( length, weight, head circumference ) will be compared between two groups.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
      • Qazvin, Iran, Islamic Republic of
        • Recruiting
        • Qazvin university of medical science, Kosar hospital
        • Contact:
        • Principal Investigator:
          • shokooh Abotorabi, assistant professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

gestational age of 24-26weeks,mild hypocalcemia (ca=8-8.6mg/dl),singleton pregnancy, body mass index (BMI) of 19-26 -

Exclusion Criteria:

moderate to sever hypocalcemia(ca<8mg/dl), gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vitamin D3, prenatal multivitamin
vitamin D3 50,000 unit/week for 8 weeks, daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
Drug: vitamin D3 50,000 unit
vitamin D3 50,000 unit/week for 8 weeks
Drug: prenatal multivitamin
daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
Active Comparator: prenatal multivitamin
daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
Drug: prenatal multivitamin
daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of hypocalcemic subjects at the ens of study
Time Frame: 12-14 weeks
women in 24-26 weeks of pregnancy will be enrolled.Outcomes will be measured at delivery time.
12-14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changing of maternal mean calcium level
Time Frame: 12-14 weeks
12-14 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal weight gain
Time Frame: 12-14 weeks
12-14 weeks
neonatal serum calcium level
Time Frame: 12-14 weeks
12-14 weeks
neonatal growth indices
Time Frame: 12-14 weeks
neonatal growth indices include neonatal weight, head circumference, length
12-14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Sima Hashemipour

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 19, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hypocalcemia of pregnancy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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