Vitamin D Supplementation During Lactation

Not Applicable

Completed

• Conditions: Deficiency, Vitamin D
• Interventions: Drug: Calciferol; Drug: placebo

• Registration Number: NCT02297568
• Lead Sponsor: Rajavithi Hospital

Brief 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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-21
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calciferol,1800 IU/d supplement	Calciferol	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 .
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.

Primary Outcome Measures

Name	Time	Method
Comparison serum 25OHD levels from breastfed infants	6 weeks after delivery

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand