The Effects of Vitamin D2 Supplement During Pregnancy

Not Applicable

Completed

• Conditions: Pregnancy Early
• Interventions: Drug: Calciferol; Drug: Placebo

• Registration Number: NCT03743922
• Lead Sponsor: Rajavithi Hospital

Brief Summary

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

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

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-11-01
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-14
• Primary Completion: 2018-11-15
• Study First Posted: 2018-11-16
• Study Completion: 2020-05-30
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral calciferol group	Calciferol	Subjects will receive oral calciferol 20,000 iu per week during pregnancy until delivered
oral placebo group	Placebo	Subjects will receive oral placebo 1 tab per week during pregnancy until delivered

Primary Outcome Measures

Name	Time	Method
effect of vitamin D 2 supplementation during pregnancy	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 Outcome Measures

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

Trial Locations

Locations (1)

Rajavithi hospital; 🇹🇭 Bangkok, Thailand