Vitamin D Treatment and Hypocalcemic Pregnant Women

• ClinicalTrials.gov Identifier: NCT02021864
• Recruitment Status: Unknown
• First Posted: December 27, 2013
• Last Update Posted: January 22, 2014
• Sponsor: Dr. Sima Hashemipour
• Information provided by (Responsible Party): Dr. Sima Hashemipour, Sina Hospital, Iran

Tracking Information

• First Submitted Date: December 20, 2013
• First Posted Date: December 27, 2013
• Last Update Posted Date: January 22, 2014
• Study Start Date: January 2014
• Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 20, 2013)

percentage of hypocalcemic subjects at the ens of study [ Time Frame: 12-14 weeks ]

women in 24-26 weeks of pregnancy will be enrolled.Outcomes will be measured at delivery time.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: December 20, 2013): Changing of maternal mean calcium level [ Time Frame: 12-14 weeks ]
• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: December 27, 2013)

• maternal weight gain [ Time Frame: 12-14 weeks ]
• neonatal serum calcium level [ Time Frame: 12-14 weeks ]
• neonatal growth indices [ Time Frame: 12-14 weeks ]
  neonatal growth indices include neonatal weight, head circumference, length

Original Other Pre-specified Outcome Measures (submitted: December 20, 2013)

maternal weight gain, neonatal serum calcium level, neonatal growth indices [ Time Frame: 12-14 weeks ]

neonatal growth indices include length.head circumference and weight

Descriptive Information

• Brief Title: Vitamin D Treatment and Hypocalcemic Pregnant Women
• Official Title: Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pregnancy Complications

Intervention

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

Study Arms

• Experimental: vitamin D3, 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
  Interventions:

  • Drug: vitamin D3 50,000 unit
  • Drug: prenatal multivitamin
• Active Comparator: prenatal multivitamin
  daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
  Intervention: Drug: prenatal multivitamin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 20, 2013): 120
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Eligibility 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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Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 16 Years to 45 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Iran, Islamic Republic of

Administrative Information

• NCT Number: NCT02021864
• Other Study ID Numbers: hypocalcemia of pregnancy
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Sima Hashemipour, Sina Hospital, Iran
• Study Sponsor: Dr. Sima Hashemipour
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sina Hospital, Iran
• Verification Date: January 2014