Vitamin D Supplementation During Lactation

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-06-30

Brief Summary

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This randomized, placebo-controlled trial in Thai pregnancy is conducted. The study aims to determine whether vitamin D3 1,800 IU/d supplementation in lactating mother improves vitamin D status of breastfed infant.

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Detailed Description

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Vitamin D deficiency in pregnancy increases risk of gestational diabetes mellitus, pre-eclampsia, preterm birth, low birth weight and cesarean section. To against these adverse events, vitamin D supplementation in pregnancy and lactation is recommended, but dose ranges are varied. Then, this study is carried out in lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester. Subjects are divided into 2 groups, one is randomly assigned to 1,800 IU/d compared with maternal and infant controls receiving placebo. Maternal serum 25OHD and milk VitD will be measured by LC-MS/MS during lactation, and on cord blood at 6 weeks breastfed infants. This study is submitted for ethical consideration by relevant Ethics committee.

Conditions

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Deficiency, Vitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Calciferol,1800 IU/d supplement

The lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester were randomly assigned to 1,800 IU/d .

Group Type ACTIVE_COMPARATOR

Calciferol

Intervention Type DRUG

Comparison 25OHD levels between calciferol and placebo

Placebo

The lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester were randomly assigned to receive placebo.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Calciferol

Comparison 25OHD levels between calciferol and placebo

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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Vitamin D3

Eligibility Criteria

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Inclusion Criteria

* Pregnant Thai women and intends to deliver at Rajavithi Hospital
* Insufficient Vitamin D levels (25(OH)D \< 30ng/ml)
* Gestational age at birth and no complications