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Vitamin D Supplementation During Lactation

Primary Purpose

Deficiency, Vitamin D

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Calciferol
placebo
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deficiency, Vitamin D focused on measuring Breast-fed infant, vitamin D supplementation, Lactation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Calciferol,1800 IU/d supplement

Placebo

Arm 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 .

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.

Outcomes

Primary Outcome Measures

Comparison serum 25OHD levels from breastfed infants

Secondary Outcome Measures

Full Information

First Posted
November 10, 2014
Last Updated
October 21, 2020
Sponsor
Rajavithi Hospital
Collaborators
Queen Sirikit National Institute of Child Health
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1. Study Identification

Unique Protocol Identification Number
NCT02297568
Brief Title
Vitamin D Supplementation During Lactation
Official Title
Randomized Control Trial of Vitamin D Supplementation During Lactation on Vitamin D in Maternal Milk
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital
Collaborators
Queen Sirikit National Institute of Child Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deficiency, Vitamin D
Keywords
Breast-fed infant, vitamin D supplementation, Lactation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calciferol,1800 IU/d supplement
Arm Type
Active Comparator
Arm 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 .
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Calciferol
Other Intervention Name(s)
Vitamin D3
Intervention Description
Comparison 25OHD levels between calciferol and placebo
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Comparison serum 25OHD levels from breastfed infants
Time Frame
6 weeks after delivery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sathit Niramitmahapanya, MD
Organizational Affiliation
Rajavithi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

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Vitamin D Supplementation During Lactation

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