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The Effects of Vitamin D2 Supplement During Pregnancy

NCT ID: NCT03743922

Last Updated: 2024-12-03

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-05-30

Brief Summary

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

Detailed Description

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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

Conditions

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Pregnancy Early

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oral calciferol group

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

Group Type EXPERIMENTAL

Calciferol

Intervention Type DRUG

calciferol capsule

oral placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo capsule

Interventions

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Calciferol

calciferol capsule

Intervention Type DRUG

Placebo

placebo capsule

Intervention Type DRUG

Other Intervention Names

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vitimin d2 placebo ( for calciferol )

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patitta Vacharaprechaskul

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Services Ministry of Public Health of Thailand

Locations

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Rajavithi hospital

Bangkok, Thailand, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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THAIVITD2

Identifier Type: -

Identifier Source: org_study_id