Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2021-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D supplemented group

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

Group Type EXPERIMENTAL

Vitamin D 2

Intervention Type DRUG

Vitamin D2 20000IU 1 tab oral weekly

Placebo group

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

Group Type EXPERIMENTAL

Placebo drug

Intervention Type DRUG

Placebo drugs 1 tab oral weekly

Interventions

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Vitamin D 2

Vitamin D2 20000IU 1 tab oral weekly

Intervention Type DRUG

Placebo drug

Placebo drugs 1 tab oral weekly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes