The Effect of Vitamin D3 Therapy on Vitamin D Status in Pregnant Women With Vitamin D Deficient and Insufficient

• Status: Active, not recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: Female

Summary

This study is a randomized controlled trial which compares the effect of vitamin D3 therapy 5,000 IU daily and 50,000 IU on 25(OH)D and 1,25(OH)2D, VDBP, and 24,25(OH)2D maternal serum levels in pregnant women with vitamin D deficient and insufficient.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indonesia University
• Treatments: Cholecalciferol; Vitamin D

Criteria

Inclusion Criteria:

• pregnant women with gestational age of ≤ 14 weeks

• vitamin D deficient or insufficient (25(OH)D <30 ng/ml]

• positive fetal heart rate from ultrasound examination.

Exclusion Criteria:

• multiple pregnancy

• pregnancy with congenital anomaly

• hyperemesis gravidarum, diarrhea

• complicated medical history (hypertension, diabetes mellitus, heart, kidney, or liver disease)

• use of any dietary supplement containing vitamin D prior to enrolment