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Vitamin D Treatment and Hypocalcemic Pregnant Women

This study is currently recruiting participants.
Verified January 2014 by Sina Hospital, Iran
Sponsor:
Information provided by (Responsible Party):
Dr. Sima Hashemipour, Sina Hospital, Iran
ClinicalTrials.gov Identifier:
NCT02021864
First received: December 20, 2013
Last updated: January 19, 2014
Last verified: January 2014
  Purpose
  • 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.

Condition Intervention
Pregnancy Complications
Drug: vitamin D3 50,000 unit
Drug: prenatal multivitamin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia

Resource links provided by NLM:


Further study details as provided by Sina Hospital, Iran:

Primary Outcome Measures:
  • percentage of hypocalcemic subjects at the ens of study [ Time Frame: 12-14 weeks ] [ Designated as safety issue: No ]
    women in 24-26 weeks of pregnancy will be enrolled.Outcomes will be measured at delivery time.


Secondary Outcome Measures:
  • Changing of maternal mean calcium level [ Time Frame: 12-14 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • maternal weight gain [ Time Frame: 12-14 weeks ] [ Designated as safety issue: No ]
  • neonatal serum calcium level [ Time Frame: 12-14 weeks ] [ Designated as safety issue: No ]
  • neonatal growth indices [ Time Frame: 12-14 weeks ] [ Designated as safety issue: No ]
    neonatal growth indices include neonatal weight, head circumference, length


Estimated Enrollment: 120
Study Start Date: January 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Active Comparator: prenatal multivitamin
daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
Drug: prenatal multivitamin
daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02021864

Contacts
Contact: Sima Hashemipour, assisstant prefessor 00989123575592 Hashemipour.sima@yahoo.com

Locations
Iran, Islamic Republic of
Qazvin university of medical science, Kosar hospital Recruiting
Qazvin, Iran, Islamic Republic of
Contact: shokooh Abotorabi, assistant professor    00989121822663    Abotorabi4242@yahoo.com   
Principal Investigator: shokooh Abotorabi, assistant professor         
Sponsors and Collaborators
Dr. Sima Hashemipour
  More Information

No publications provided

Responsible Party: Dr. Sima Hashemipour, assistant professor of endocrinology and metabolism, Sina Hospital, Iran
ClinicalTrials.gov Identifier: NCT02021864     History of Changes
Other Study ID Numbers: hypocalcemia of pregnancy
Study First Received: December 20, 2013
Last Updated: January 19, 2014
Health Authority: Iran: Ministry of health and medical education.

Keywords provided by Sina Hospital, Iran:
hypocalcemia, pregnancy, vitamin D

Additional relevant MeSH terms:
Pregnancy Complications
Hypocalcemia
Vitamin D Deficiency
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 16, 2014