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

Department of Medical Services Ministry of Public Health of Thailand60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy

Interventions

Vitamin D 2DRUG

Vitamin D2 20000IU 1 tab oral weekly

Placebo drugDRUG

Placebo drugs 1 tab oral weekly

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rajavithi hospital

Bangkok, Thailand

Outcomes

Primary Outcomes

Serum 25-OH vitamin D level in pregnant women

measure in nmol/L

Time frame: At delivery time

Serum 25-OH vitamin D level in umbilicalcord blood

measure in nmol/L

Time frame: At delivery time

Secondary Outcomes

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

Time frame: During pregnancy until delivery

Preterm birth

Delivery before GA 37 weeks

Time frame: At delivery time

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

Time frame: At delivery time

Infant birth weight

measure in kilograms

Time frame: At delivery time

Infant length

Data from ClinicalTrials.gov

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