The Effects of Vitamin D2 Supplement During Pregnancy

NCT03743922 | Completed DMC

• 1 other identifier: THAIVITD2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Early

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• vitamin D levels in maternal blood during pregnancy

  at first time ANC

• vitamin D levels in maternal blood after vitamin D supplementation

  within 30 minute after delivered

Study Arms (2)

Oral calciferol group

EXPERIMENTAL

Subjects will receive oral calciferol 20,000 iu per week during pregnancy until delivered

Drug: Calciferol

oral placebo group

PLACEBO COMPARATOR

Subjects will receive oral placebo 1 tab per week during pregnancy until delivered

Drug: Placebo

Interventions

Calciferol DRUG

calciferol capsule

Also known as: vitimin d2

Oral calciferol group

Placebo DRUG

placebo capsule

Also known as: placebo ( for calciferol )

oral placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi hospital

Bangkok, Thailand, 10400, Thailand

Location

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Patitta Vacharaprechaskul

  Department of Medical Services Ministry of Public Health of Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 16, 2018
• Study Start: November 1, 2018
• Primary Completion: November 15, 2018
• Study Completion: May 30, 2020
• Last Updated: December 3, 2024

Record last verified: 2018-10

Locations

TH (1)