Status:
UNKNOWN
The Effect of Vitamin D3 Therapy on Vitamin D Status in Pregnant Women With Vitamin D Deficient and Insufficient
Lead Sponsor:
Indonesia University
Conditions:
Vitamin D Deficiency
Eligibility:
FEMALE
Phase:
PHASE2
PHASE3
Brief 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 pregn...
Detailed Description
This is a randomized controlled trial of vitamin D therapy of 5,000 IU daily or 50,000 IU weekly during pregnancy. The study is conducted at Cipto Mangunkusumo National Center General Hospital and Koj...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06054919
Start Date
April 1 2021
End Date
November 30 2023
Last Update
September 26 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cipto Mangunkusumo National Center General Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 13730