Vitamin D Supplementation During Lactation

Study Overview
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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.

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.

Official Title
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Randomized Control Trial of Vitamin D Supplementation During Lactation on Vitamin D in Maternal Milk

Conditions
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Deficiency, Vitamin D

Intervention / Treatment
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* Drug: Calciferol
* Drug: placebo


Participation Criteria
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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 Exclusion Criteria: Age < 18 years old Unintended to deliver at Rajavithi Hospital Insufficient Vitamin D levels (25(OH)D < 10ng/ml)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calciferol,1800 IU/d supplement<br>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 . | Drug: Calciferol<br>* Comparison 25OHD levels between calciferol and placebo<br>* Other names: Vitamin D3;|
| Placebo Comparator: Placebo<br>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. | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison serum 25OHD levels from breastfed infants |  | 6 weeks after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast-fed infant, vitamin D supplementation, Lactation