Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy

Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy Clinical Trial

Official title:

Pregnancy Outcomes and Vitamin D Level Among Vitamin D Supplementation During Pregnancy : A Double-blind Randomized Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591847
• Other study ID #: 121/2563
• Status: Completed
• Phase: Phase 3
• Start date: October 19, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2020
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compared pregnancy outcome (Serum vitamin D level in mother and infant , preeclampsia rate, preterm birth rate, Infant birth weight, Infant length , APGAR score) between pregnant women who were given vitamin D supplementation and pregnant women who were given placebo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Thai female
• Singleton pregnancy
• Age at 18 years old or more
• Gestational age at 18-22 weeks
• Accept to enroll

Exclusion Criteria:

• Pregnant women who not planned to delivery at Rajavithi hospital
• Abnormal kidney function
• Use antiepileptic drugs , or vitamin D supplementation
• Allergy to vitamin D
• Who were diagnosed as vitamin D deficiency

Related Conditions & MeSH terms

• Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy

Intervention

Drug:
• Vitamin D 2
Vitamin D2 20000IU 1 tab oral weekly
• Placebo drug
Placebo drugs 1 tab oral weekly

Locations

Country	Name	City	State
Thailand	Rajavithi hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25-OH vitamin D level in pregnant women	measure in nmol/L	At delivery time
Primary	Serum 25-OH vitamin D level in umbilicalcord blood	measure in nmol/L	At delivery time
Secondary	Preeclampsia	Measure by clinical and laboratory of preeclampsia; ?high blood pressure ( >= 140/90 mmHg) with proteinuria (UPCI > 0.3 mg/dL or Urine protein 24 hours > 300 mg) or in absence of proteinuria with new onset of any of the following; thrombocytopenia : Platelet count less than 100,000 x 10^9 /L; Serum creatinine > 1.1 mg/dL or doubling of the serum creatinine; Elevated liver transaminases to twice normal; Pulmonary edema; New onset headache unresponsive to medication; Visual symptom	During pregnancy until delivery
Secondary	Preterm birth	Delivery before GA 37 weeks	At delivery time
Secondary	Infant APGAR score	Measure at delivery time score 10/10; Appearance : Cyanotic, pale all over = 0 , Peripheral cyanotic only = 1 , Pink = 2 Pulse : 0 bpm = 0 , <100 = 1, 100-140 = 2 Grimace : no response to stimulation = 0 , Grimace(facial movement ,weak cry) = 1 Cry when stimulated = 2 Activity (tone) : floppy = 0 , Some flexion = 1 , Well flexed and resisting extension = 2 Respiration : Apnoeic = 0 , Slow irregular = 1 , Strong cry = 2	At delivery time
Secondary	Infant birth weight	measure in kilograms	At delivery time
Secondary	Infant length	measure in centimeters	At delivery time