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Vitamin D Supplementation During Lactation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02297568
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : October 23, 2020
Sponsor:
Collaborator:
Queen Sirikit National Institute of Child Health
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Deficiency, Vitamin D Drug: Calciferol Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Vitamin D Supplementation During Lactation on Vitamin D in Maternal Milk
Study Start Date : March 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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 .
Drug: Calciferol
Comparison 25OHD levels between calciferol and placebo
Other Name: Vitamin D3

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.
Drug: placebo



Primary Outcome Measures :
  1. Comparison serum 25OHD levels from breastfed infants [ Time Frame: 6 weeks after delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297568


Locations
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Thailand
Rajavithi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Rajavithi Hospital
Queen Sirikit National Institute of Child Health
Investigators
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Principal Investigator: Sathit Niramitmahapanya, MD Rajavithi Hospital
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Responsible Party: Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT02297568    
Other Study ID Numbers: RJVITD001
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: July 2015
Keywords provided by Rajavithi Hospital:
Breast-fed infant
vitamin D supplementation
Lactation
Additional relevant MeSH terms:
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Avitaminosis
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents