Clinical trial NCT06054919: The Effect of Vitamin D3 Therapy on Vitamin D Status in Pregnant Women With Vitamin D Deficient and Insufficient
Official title: The Effect of Vitamin D3 Therapy on 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D Maternal Serum Levels in Pregnant Women With Vitamin D Deficient and Insufficient
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Vitamin D Deficiency
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 52
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 pregnant women with vitamin D deficient and insufficient.

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 Koja Distict Hospital in Jakarta, Indonesia from April 2021 - December 2023. All the pregnant women are screened for eligibility when they presented to the clinic for antenatal care visits and are offered enrolment if they meet the following inclusion criteria: gestational age of ≤ 14 weeks, vitamin D deficient or insufficient (25(OH)D \<30 ng/ml\], and positive fetal heart rate from ultrasound examination.

Participants are randomly assigned to one of two parallel intervention groups, with allocation concealment: vitamin D3 (cholecalciferol) 5,000 IU/week or 50,000 IU/week. All participants are given a standard prenatal multivitamin. A medical history, physical, and ultrasound examination are performed. Participants complete a questionnaire about sunlight exposure. Interventions in both groups are given for four weeks. Baseline blood tests, including serum 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D are performed at recruitment. After four weeks of interventions, the maternal venous blood is collected to assess serum 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D.

Eligibility 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

Primary outcomes:
measure: 25(OH)D maternal serum level
timeFrame: 4 weeks after intervention
measure: 1,25(OH)2D maternal serum level
timeFrame: 4 weeks after intervention
measure: VDBP maternal serum level
timeFrame: 4 weeks after intervention
measure: 24,25(OH)2D maternal serum level
timeFrame: 4 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo National Center General Hospital
state: DKI Jakarta
Study officials:
affiliation: Departement of Obstetrics and Gynecology, Faculty of Medicine University of Indonesia
name: Rima Irwinda, MD, PhD
role: STUDY_CHAIR
References: