NCT04591847

Brief Summary

To compared pregnancy outcome (Serum vitamin D level in mother and infant , preeclampsia rate, preterm birth rate, Infant birth weight, Infant length , APGAR score) between pregnant women who were given vitamin D supplementation and pregnant women who were given placebo

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 19, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

September 13, 2021

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

September 14, 2020

Last Update Submit

September 10, 2021

Conditions

Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy

Keywords

Vitamin D25-hydroxyvitamin DPregnancyInfant

Outcome Measures

Primary Outcomes (2)

  • Serum 25-OH vitamin D level in pregnant women

    measure in nmol/L

    At delivery time

  • Serum 25-OH vitamin D level in umbilicalcord blood

    measure in nmol/L

    At delivery time

Secondary Outcomes (5)

  • Preeclampsia

    During pregnancy until delivery

  • Preterm birth

    At delivery time

  • Infant APGAR score

    At delivery time

  • Infant birth weight

    At delivery time

  • Infant length

    At delivery time

Study Arms (2)

Vitamin D supplemented group

EXPERIMENTAL

Vitamin D2 20000 IU 1 tab oral weekly start at GA 18 -22 weeks until delivery

Drug: Vitamin D 2

Placebo group

EXPERIMENTAL

Placebo drug (Appearance same as Vitamin D2) 1 tab oral weekly start at GA 18 -22 weeks until delivery

Drug: Placebo drug

Interventions

Vitamin D 2DRUG

Vitamin D2 20000IU 1 tab oral weekly

Vitamin D supplemented group
Placebo drugDRUG

Placebo drugs 1 tab oral weekly

Placebo group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Thai female
  • Singleton pregnancy
  • Age at 18 years old or more
  • Gestational age at 18-22 weeks
  • Accept to enroll

You may not qualify if:

  • Pregnant women who not planned to delivery at Rajavithi hospital
  • Abnormal kidney function
  • Use antiepileptic drugs , or vitamin D supplementation
  • Allergy to vitamin D
  • Who were diagnosed as vitamin D deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

Ergocalciferols

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

October 19, 2020

Study Start

October 19, 2020

Primary Completion

July 31, 2021

Study Completion

August 31, 2021

Last Updated

September 13, 2021

Record last verified: 2020-10

Locations

TH(1)