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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pregnancy Complications Drug: vitamin D3 50,000 unit Drug: prenatal multivitamin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia
Study Start Date : January 2014
Estimated Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changing of maternal mean calcium level [ Time Frame: 12-14 weeks ]

Other Outcome Measures:
  1. maternal weight gain [ Time Frame: 12-14 weeks ]
  2. neonatal serum calcium level [ Time Frame: 12-14 weeks ]
  3. neonatal growth indices [ Time Frame: 12-14 weeks ]
    neonatal growth indices include neonatal weight, head circumference, length


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021864


Contacts
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Contact: Sima Hashemipour, assisstant prefessor 00989123575592 Hashemipour.sima@yahoo.com

Locations
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Iran, Islamic Republic of
Qazvin university of medical science, Kosar hospital Recruiting
Qazvin, Iran, Islamic Republic of
Contact: shokooh Abotorabi, assistant professor    00989121822663    Abotorabi4242@yahoo.com   
Principal Investigator: shokooh Abotorabi, assistant professor         
Sponsors and Collaborators
Dr. Sima Hashemipour
More Information
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Responsible Party: Dr. Sima Hashemipour, assistant professor of endocrinology and metabolism, Sina Hospital, Iran
ClinicalTrials.gov Identifier: NCT02021864    
Other Study ID Numbers: hypocalcemia of pregnancy
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Dr. Sima Hashemipour, Sina Hospital, Iran:
hypocalcemia, pregnancy, vitamin D
Additional relevant MeSH terms:
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Pregnancy Complications
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Calcium
 Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents