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

Study Overview
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Brief Summary
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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

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

Conditions
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Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy

Intervention / Treatment
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* Drug: Vitamin D 2
* Drug: Placebo drug


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D supplemented group<br>Vitamin D2 20000 IU 1 tab oral weekly start at GA 18 -22 weeks until delivery | Drug: Vitamin D 2<br>* Vitamin D2 20000IU 1 tab oral weekly<br>|
| Experimental: Placebo group<br>Placebo drug (Appearance same as Vitamin D2) 1 tab oral weekly start at GA 18 -22 weeks until delivery | Drug: Placebo drug<br>* Placebo drugs 1 tab oral weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25-OH vitamin D level in pregnant women | measure in nmol/L | At delivery time | 
| Serum 25-OH vitamin D level in umbilicalcord blood | measure in nmol/L | At delivery time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Preterm birth | Delivery before GA 37 weeks | 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 | At delivery time | 
| Infant birth weight | measure in kilograms | At delivery time | 
| Infant length | measure in centimeters | At delivery time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, 25-hydroxyvitamin D, Pregnancy, Infant