Vitamin D Treatment and Hypocalcemic Pregnant Women

Not Applicable

• Conditions: Pregnancy Complications
• Interventions: Drug: prenatal multivitamin; Drug: vitamin D3 50,000 unit

• Registration Number: NCT02021864
• Lead Sponsor: Dr. Sima Hashemipour

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 available

Study Timeline

• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Status Verified: 2014-01
• Study Start: 2014-01
• Last Update Submitted: 2014-01-19
• Last Update Posted: 2014-01-22
• Primary Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
percentage of hypocalcemic subjects at the ens of study	12-14 weeks	women in 24-26 weeks of pregnancy will be enrolled.Outcomes will be measured at delivery time.

Secondary Outcome Measures

Name	Time	Method
Changing of maternal mean calcium level	12-14 weeks

Trial Locations

Locations (1)

Qazvin university of medical science, Kosar hospital; 🇮🇷 Qazvin, Iran, Islamic Republic of