Vitamin D Supplementation During Lactation

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

Sponsors

Lead Sponsor: Rajavithi Hospital

Collaborator: Queen Sirikit National Institute of Child Health

Source 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.

Overall Status Completed
Start Date March 2014
Completion Date June 2015
Primary Completion Date June 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Comparison serum 25OHD levels from breastfed infants 6 weeks after delivery
Enrollment 80
Condition
Intervention

Intervention Type: Drug

Intervention Name: Calciferol

Description: Comparison 25OHD levels between calciferol and placebo

Arm Group Label: Calciferol,1800 IU/d supplement

Other Name: Vitamin D3

Intervention Type: Drug

Intervention Name: placebo

Arm Group Label: Placebo

Eligibility

Criteria:

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)

Gender: Female

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Sathit Niramitmahapanya, MD Principal Investigator Rajavithi Hospital
Location
Facility: Rajavithi Hospital
Location Countries

Thailand

Verification Date

July 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Rajavithi Hospital

Investigator Full Name: Kanya Boonthongtho

Investigator Title: Dr Sathit Niramitmahapanya

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Calciferol,1800 IU/d supplement

Type: Active Comparator

Description: 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 .

Label: Placebo

Type: Placebo Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov