The Effects of Vitamin D2 Supplement During Pregnancy

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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Early
• Intervention / Treatment: Drug: Placebo; Drug: Calciferol

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rajavithi Hospital
• Investigators: Principal Investigator: Patitta Vacharaprechaskul, Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): November 15, 2018
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Ergocalciferols
• Other Study ID Numbers: THAIVITD2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No