Pregnancy Complications
Conditions
Keywords
hypocalcemia, pregnancy, vitamin D
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.
Interventions
DRUGvitamin D3 50,000 unit
vitamin D3 50,000 unit/week for 8 weeks
DRUGprenatal multivitamin
daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
Sponsors
Dr. Sima Hashemipour
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Changing of maternal mean calcium level | 12-14 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| maternal weight gain | 12-14 weeks | — |
| neonatal serum calcium level | 12-14 weeks | — |
| neonatal growth indices | 12-14 weeks | neonatal growth indices include neonatal weight, head circumference, length |
Countries
Iran
Contacts
Primary ContactSima Hashemipour, assisstant prefessor
Outcome results
None listed