Vitamin D Treatment and Hypocalcemic Pregnant Women

Pregnancy Complications Clinical Trial

Official title:

Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02021864
• Other study ID #: hypocalcemia of pregnancy
• Status: Recruiting
• Phase: N/A
• First received: December 20, 2013
• Last updated: January 19, 2014
• Start date: January 2014

Study information

• Verified date: January 2014
• Source: Sina Hospital, Iran
• Contact: Sima Hashemipour, assisstant prefessor
• Phone: 00989123575592
• Email: Hashemipour.sima[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ministry of health and medical education.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Qazvin university of medical science, Kosar hospital	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sima Hashemipour

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	maternal weight gain		12-14 weeks	No
Other	neonatal serum calcium level		12-14 weeks	No
Other	neonatal growth indices	neonatal growth indices include neonatal weight, head circumference, length	12-14 weeks	No
Primary	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	No
Secondary	Changing of maternal mean calcium level		12-14 weeks	No