The Effects of Vitamin D2 Supplement During Pregnancy

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 15, 2018

Detailed Description

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

Interventions

  • Drug: Calciferol
    • calciferol capsule
  • Drug: Placebo
    • placebo capsule

Arms, Groups and Cohorts

  • Experimental: Oral calciferol group
    • Subjects will receive oral calciferol 20,000 iu per week during pregnancy until delivered
  • Placebo Comparator: oral placebo group
    • Subjects will receive oral placebo 1 tab per week during pregnancy until delivered

Clinical Trial Outcome Measures

Primary Measures

  • effect of vitamin D 2 supplementation during pregnancy
    • Time Frame: within 30 minute after delivered
    • 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

Secondary Measures

  • vitamin D levels in maternal blood during pregnancy
    • Time Frame: at first time ANC
    • To assess vitamin D levels in maternal blood during pregnancy
  • vitamin D levels in maternal blood after vitamin D supplementation
    • Time Frame: within 30 minute after delivered
    • To assess vitamin D levels in maternal blood after vitamin D supplementation during pregnancy

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rajavithi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Patitta Vacharaprechaskul, Principal Investigator, Rajavithi Hospital

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