Trial | NCT02021864  Report issue

Title

Vitamin D Treatment and Hypocalcemic Pregnant Women
Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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.
Study Started
Jan 31
2014
Primary Completion
Oct 31
2014
Anticipated
Last Update
Jan 22
2014
Estimate

Drug prenatal multivitamin

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

vitamin D3, prenatal multivitamin Experimental

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

prenatal multivitamin Active Comparator

daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit

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

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No Results Posted