Vitamin D Treatment and Hypocalcemic Pregnant Women
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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
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- 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 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 |
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
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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
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Drug: prenatal multivitamin
daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit |
- 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.
- Changing of maternal mean calcium level [ Time Frame: 12-14 weeks ]
- 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

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Ages Eligible for Study: | 16 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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
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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
Contact: Sima Hashemipour, assisstant prefessor | 00989123575592 | Hashemipour.sima@yahoo.com |
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 |
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 |
hypocalcemia, pregnancy, vitamin D |
Pregnancy Complications Vitamin D Cholecalciferol Vitamins Micronutrients |
Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |