- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02297568
Vitamin D Supplementation During Lactation
October 21, 2020 updated by: Rajavithi Hospital
Randomized Control Trial of Vitamin D Supplementation During Lactation on Vitamin D in Maternal Milk
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bangkok, Thailand, 10400
- Rajavithi Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Calciferol,1800 IU/d supplement
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 .
|
Comparison 25OHD levels between calciferol and placebo
Other Names:
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Placebo Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison serum 25OHD levels from breastfed infants
Time Frame: 6 weeks after delivery
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6 weeks after delivery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sathit Niramitmahapanya, MD, Rajavithi Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
November 10, 2014
First Submitted That Met QC Criteria
November 20, 2014
First Posted (Estimate)
November 21, 2014
Study Record Updates
Last Update Posted (Actual)
October 23, 2020
Last Update Submitted That Met QC Criteria
October 21, 2020
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RJVITD001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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