NCT02297568

Vitamin D Supplementation During Lactation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Department of Medical Services Ministry of Public Health of Thailand · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

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

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

• Deficiency, Vitamin D

Interventions

Type	Name	Description
DRUG	Calciferol	Comparison 25OHD levels between calciferol and placebo
DRUG	placebo

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-11-21
• Last updated: 2020-10-23

Locations

1 site across 1 country: Thailand