NCT02021864

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

9 months

First QC Date

December 20, 2013

Last Update Submit

January 19, 2014

Conditions

Pregnancy Complications

Keywords

hypocalcemia, pregnancy, vitamin D

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Changing of maternal mean calcium level

    12-14 weeks

Other Outcomes (3)

  • maternal weight gain

    12-14 weeks

  • neonatal serum calcium level

    12-14 weeks

  • neonatal growth indices

    12-14 weeks

Study Arms (2)

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

Drug: vitamin D3 50,000 unitDrug: prenatal multivitamin

prenatal multivitamin

ACTIVE COMPARATOR

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

Drug: prenatal multivitamin

Interventions

vitamin D3 50,000 unitDRUG

vitamin D3 50,000 unit/week for 8 weeks

vitamin D3, prenatal multivitamin
prenatal multivitaminDRUG

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

prenatal multivitaminvitamin D3, prenatal multivitamin

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • gestational age of 24-26weeks,mild hypocalcemia (ca=8-8.6mg/dl),singleton pregnancy, body mass index (BMI) of 19-26 -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qazvin university of medical science, Kosar hospital

Qazvin, Qazvin Province, Iran

RECRUITING

Related Publications (1)

  • Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.

    PMID: 39077939DERIVED

MeSH Terms

Conditions

Pregnancy ComplicationsHypocalcemia

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Central Study Contacts

Sima Hashemipour, assisstant prefessor

CONTACT

00989123575592Hashemipour.sima@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor of endocrinology and metabolism

Study Record Dates

First Submitted

December 20, 2013

First Posted

December 27, 2013

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

IR(1)