The Effects of Vitamin D2 Supplement During Pregnancy

Study Overview
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Brief Summary
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The effects of vitamin D2 supplement during pregnancy on postpartum maternal and fetal vitamin D levels: the randomized controlled trial

Detailed Description
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Vitamin D structurally similar to steroids. Made from the skin. And metabolism of the liver, kidneys, vitamin D levels in the bloodstream are two types of vitamin D 2 (Ergocalciferol) and vitamin D 3 (Cholecalciferol) Vitamin D regulates calcium and phosphorus levels in the body. Including the accumulation of minerals in the bone. Vitamin D is important in the formation of bones and teeth and the normal growth of children, affects the reabsorption of amino acids in the kidneys, regulates the amount of calcium and phosphorus in the blood Vitamin D deficiency in pregnant affects the mother and baby example high maternal blood pressure during pregnancy, diabetes during pregnancy, increase birth body weight of baby. low calcium seizures Infants, baby have bones and growth disorders. Currently, no vitamin D supplement is used in pregnant women in Thailand who attend antenatal clinics. The researcher has proposed to study the effects of vitamin D supplement during pregnancy on postpartum maternal and fetal vitamin D levels by using vitamin D 20,000IU / week

Official Title
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The Effects of Vitamin D2 Supplement During Pregnancy on Postpartum Maternal and Fetal Vitamin D Levels: the Randomized Controlled Trial

Conditions
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Pregnancy Early

Intervention / Treatment
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* Drug: Calciferol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who have pregnant and ANC at Rajavithi hospital Women who have age at least 18 year Women who have Thai nationality Women who have pregnant of gestational age under 20week Exclusion Criteria: Women who don't plan of delivered at Rajavithi hospital Women who have complication of pregnancy Woman who delivered before gestational age 37week Women who have abnormal kidney function Woman who have been used anticonvulsant drug or others form of vitamin d Women who have vitamin d allergy

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral calciferol group<br>Subjects will receive oral calciferol 20,000 iu per week during pregnancy until delivered | Drug: Calciferol<br>* calciferol capsule<br>* Other names: vitimin d2;|
| Placebo Comparator: oral placebo group<br>Subjects will receive oral placebo 1 tab per week during pregnancy until delivered | Drug: Placebo<br>* placebo capsule<br>* Other names: placebo ( for calciferol );|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of vitamin D 2 supplementation during pregnancy | To study the effect of vitamin D 2 supplementation during pregnancy on postpartum maternal and fetal vitamin D levels effects of vitamin D2 supplement during pregnancy on postpartum maternal and fetal vitamin D levels | within 30 minute after delivered | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitamin D levels in maternal blood during pregnancy | To assess vitamin D levels in maternal blood during pregnancy | at first time ANC | 
| vitamin D levels in maternal blood after vitamin D supplementation | To assess vitamin D levels in maternal blood after vitamin D supplementation during pregnancy | within 30 minute after delivered |