search
Back to results

Vitamin D Treatment and Hypocalcemic Pregnant Women

Primary Purpose

Pregnancy Complications

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
vitamin D3 50,000 unit
prenatal multivitamin
Sponsored by
Dr. Sima Hashemipour
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Complications focused on measuring hypocalcemia, pregnancy, vitamin D

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

-

Sites / Locations

  • Qazvin university of medical science, Kosar hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

vitamin D3, prenatal multivitamin

prenatal multivitamin

Arm Description

vitamin D3 50,000 unit/week for 8 weeks, daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit

daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit

Outcomes

Primary Outcome Measures

percentage of hypocalcemic subjects at the ens of study
women in 24-26 weeks of pregnancy will be enrolled.Outcomes will be measured at delivery time.

Secondary Outcome Measures

Changing of maternal mean calcium level

Full Information

First Posted
December 20, 2013
Last Updated
January 19, 2014
Sponsor
Dr. Sima Hashemipour
search

1. Study Identification

Unique Protocol Identification Number
NCT02021864
Brief Title
Vitamin D Treatment and Hypocalcemic Pregnant Women
Official Title
Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Sima Hashemipour

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications
Keywords
hypocalcemia, pregnancy, vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vitamin D3, prenatal multivitamin
Arm Type
Experimental
Arm Description
vitamin D3 50,000 unit/week for 8 weeks, daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
Arm Title
prenatal multivitamin
Arm Type
Active Comparator
Arm Description
daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
Intervention Type
Drug
Intervention Name(s)
vitamin D3 50,000 unit
Intervention Description
vitamin D3 50,000 unit/week for 8 weeks
Intervention Type
Drug
Intervention Name(s)
prenatal multivitamin
Intervention Description
daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
Primary Outcome Measure Information:
Title
percentage of hypocalcemic subjects at the ens of study
Description
women in 24-26 weeks of pregnancy will be enrolled.Outcomes will be measured at delivery time.
Time Frame
12-14 weeks
Secondary Outcome Measure Information:
Title
Changing of maternal mean calcium level
Time Frame
12-14 weeks
Other Pre-specified Outcome Measures:
Title
maternal weight gain
Time Frame
12-14 weeks
Title
neonatal serum calcium level
Time Frame
12-14 weeks
Title
neonatal growth indices
Description
neonatal growth indices include neonatal weight, head circumference, length
Time Frame
12-14 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sima Hashemipour, assisstant prefessor
Phone
00989123575592
Email
Hashemipour.sima@yahoo.com
Facility Information:
Facility Name
Qazvin university of medical science, Kosar hospital
City
Qazvin
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shokooh Abotorabi, assistant professor
Phone
00989121822663
Email
Abotorabi4242@yahoo.com
First Name & Middle Initial & Last Name & Degree
shokooh Abotorabi, assistant professor

12. IPD Sharing Statement

Learn more about this trial

Vitamin D Treatment and Hypocalcemic Pregnant Women

We'll reach out to this number within 24 hrs