Vitamin D Treatment and Hypocalcemic Pregnant Women

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia

Conditions
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Pregnancy Complications

Intervention / Treatment
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* Drug: vitamin D3 50,000 unit
* Drug: prenatal multivitamin


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12-14 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypocalcemia, pregnancy, vitamin D