Vitamin D Supplementation During Lactation

Deficiency, Vitamin D Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297568
• Other study ID #: RJVITD001
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Avitaminosis
• Deficiency, Vitamin D
• Vitamin D Deficiency

Intervention

Drug:
• Calciferol
Comparison 25OHD levels between calciferol and placebo
• placebo

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Rajavithi Hospital	Queen Sirikit National Institute of Child Health

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison serum 25OHD levels from breastfed infants		6 weeks after delivery