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Trial record 6 of 156 for:    severe preeclampsia AND Pregnancy Complications

Vitamin D Treatment and Hypocalcemic Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021864
Recruitment Status : Unknown
Verified January 2014 by Dr. Sima Hashemipour, Sina Hospital, Iran.
Recruitment status was:  Recruiting
First Posted : December 27, 2013
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Sima Hashemipour, Sina Hospital, Iran

Tracking Information
First Submitted Date  ICMJE December 20, 2013
First Posted Date  ICMJE December 27, 2013
Last Update Posted Date January 22, 2014
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02021864 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
Changing of maternal mean calcium level [ Time Frame: 12-14 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 27, 2013)
  • maternal weight gain [ Time Frame: 12-14 weeks ]
  • neonatal serum calcium level [ Time Frame: 12-14 weeks ]
  • neonatal growth indices [ Time Frame: 12-14 weeks ]
    neonatal growth indices include neonatal weight, head circumference, length
Original Other Pre-specified Outcome Measures
 (submitted: December 20, 2013)
maternal weight gain, neonatal serum calcium level, neonatal growth indices [ Time Frame: 12-14 weeks ]
neonatal growth indices include length.head circumference and weight
 
Descriptive Information
Brief Title  ICMJE Vitamin D Treatment and Hypocalcemic Pregnant Women
Official Title  ICMJE Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pregnancy Complications
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: vitamin D3 50,000 unit
    • Drug: prenatal multivitamin
  • Active Comparator: prenatal multivitamin
    daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
    Intervention: Drug: prenatal multivitamin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 20, 2013)
120
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02021864
Other Study ID Numbers  ICMJE hypocalcemia of pregnancy
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sima Hashemipour, Sina Hospital, Iran
Study Sponsor  ICMJE Dr. Sima Hashemipour
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sina Hospital, Iran
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP