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NCT Number: NCT02297568

Vitamin D Supplementation During Lactation

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.

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Key information

Conditions

Deficiency, Vitamin D Avitaminosis Behavior Breast Feeding Deficiency Diseases Feeding Behavior Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi Hospital

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Calciferol

Drug

Comparison 25OHD levels between calciferol and placebo

Other names: Vitamin D3

Placebo

Drug

Primary outcomes

  1. Comparison serum 25OHD levels from breastfed infants

    Time frame: 6 weeks after delivery

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Collaborators

  • Queen Sirikit National Institute of Child Health

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2014
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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