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

Phase 3

Completed

• Conditions: Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy
• Interventions: Drug: Vitamin D 2; Drug: Placebo drug

• Registration Number: NCT04591847
• Lead Sponsor: Rajavithi Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-14
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-12
• Study Start: 2020-10-19
• Study First Posted: 2020-10-19
• Primary Completion: 2021-07-31
• Study Completion: 2021-08-31
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D supplemented group	Vitamin D 2	Vitamin D2 20000 IU 1 tab oral weekly start at GA 18 -22 weeks until delivery
Placebo group	Placebo drug	Placebo drug (Appearance same as Vitamin D2) 1 tab oral weekly start at GA 18 -22 weeks until delivery

Primary Outcome Measures

Name	Time	Method
Serum 25-OH vitamin D level in pregnant women	At delivery time	measure in nmol/L
Serum 25-OH vitamin D level in umbilicalcord blood	At delivery time	measure in nmol/L

Secondary Outcome Measures

Name	Time	Method
Preeclampsia	During pregnancy until delivery	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
Preterm birth	At delivery time	Delivery before GA 37 weeks
Infant APGAR score	At delivery time	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
Infant birth weight	At delivery time	measure in kilograms
Infant length	At delivery time	measure in centimeters

Trial Locations

Locations (1)

Rajavithi hospital; 🇹🇭 Bangkok, Thailand