Establishing the Vitamin D Requirements During Lactation
2 other identifiers
interventional
460
1 country
2
Brief Summary
The purpose of this study is to determine the effectiveness and safety of maternal and infant vitamin D supplementation as a function of ethnicity and latitude in the prevention of vitamin D deficiency in the breastfeeding mother-infant pair. The findings of this study will generate important new information for health care professionals and policy makers with regard to vitamin D requirements and the potential benefit to both mother and infant
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2006
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 13, 2006
CompletedFirst Posted
Study publicly available on registry
December 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
June 3, 2016
CompletedJune 4, 2018
May 1, 2018
6.2 years
December 13, 2006
April 27, 2016
May 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery
to 7 months postpartum
Secondary Outcomes (2)
Maternal Health Status - Vitamin D Deficiency
to 7 months postpartum
Infant Health Status - Vitamin D Deficiency
to 7 months of age
Study Arms (3)
Control 400 IU vitamin D3
ACTIVE COMPARATOR400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad
2400 IU vitamin D3 (cholecalciferol)
EXPERIMENTAL2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
6400 IU vitamin D3 (cholecalciferol)
EXPERIMENTAL6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
Interventions
400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant
2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
Eligibility Criteria
You may qualify if:
- Mother plans to breastfeed exclusively for at least six months
- Mother is in good health
- Infant is 35 weeks' gestation or greater
- Breastfeeding infant is in good health ( Level I nursery; or Level II nursery but not requiring oxygen therapy or parenteral nutrition beyond first 72 hours).
You may not qualify if:
- Mother does not plan to breastfeed exclusively for the first six months (plans to use formula for infant's feedings during the first six months
- Infant has been admitted to Neonatal Intensive Care unit requiring oxygen therapy or parental nutrition beyond the first 72 hours
- Infant is less than 35 weeks' gestation
- Infant has been diagnosed with a congenital anomaly or abnormal chromosomal pattern
- Mother has a history of endocrine dysfunction involving parathyroid gland, diabetes, or calcium abnormalities related to renal disease such that calcium parameters are abnormal
- Mother has history of hypercalciuria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Rochester Medical Center
Rochester, New York, 14642, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Related Publications (7)
Ramadurai S, Andrews C, Cheema S, Thomas R, Wagner CL, Sen S. Maternal Predictors of Breast Milk Plasmalogens and Associations with Infant Body Composition and Neurodevelopment. Clin Ther. 2022 Jul;44(7):998-1009. doi: 10.1016/j.clinthera.2022.06.003. Epub 2022 Jul 29.
PMID: 35909001DERIVEDAndrews L, Phlegar K, Baatz JE, Ebeling MD, Shary JR, Gregoski MJ, Howard CR, Hollis BW, Wagner CL. Comparison of Infant Bone Mineral Content and Density After Infant Daily Oral Vit D 400 IU Supplementation Versus Nursing Mother Oral 6,400 IU Supplementation: A Randomized Controlled Lactation Study. Breastfeed Med. 2022 Jun;17(6):493-500. doi: 10.1089/bfm.2021.0281. Epub 2022 Mar 10.
PMID: 35271380DERIVEDPouch GG, Ebeling M, Shary JR, Hollis BW, Howard CR, Wagner CL. Evaluating Vitamin D Status in Infants Less than Seven Months; What Are the Preferred Biochemical Measurements? Breastfeed Med. 2022 May;17(5):422-428. doi: 10.1089/bfm.2021.0237. Epub 2022 Feb 23.
PMID: 35196139DERIVEDWagner CL, Hulsey TC, Ebeling M, Shary JR, Asghari G, Howard CR, Baatz JE, Newton DA, Wahlquist AE, Reed SG, Taylor SN, Lawrence RA, Hollis BW. Safety Aspects of a Randomized Clinical Trial of Maternal and Infant Vitamin D Supplementation by Feeding Type Through 7 Months Postpartum. Breastfeed Med. 2020 Dec;15(12):765-775. doi: 10.1089/bfm.2020.0056. Epub 2020 Sep 11.
PMID: 32915638DERIVEDBell KA, Wagner CL, Perng W, Feldman HA, Shypailo RJ, Belfort MB. Validity of Body Mass Index as a Measure of Adiposity in Infancy. J Pediatr. 2018 May;196:168-174.e1. doi: 10.1016/j.jpeds.2018.01.028. Epub 2018 Mar 15.
PMID: 29551311DERIVEDSen S, Penfield-Cyr A, Hollis BW, Wagner CL. Maternal Obesity, 25-Hydroxy Vitamin D Concentration, and Bone Density in Breastfeeding Dyads. J Pediatr. 2017 Aug;187:147-152.e1. doi: 10.1016/j.jpeds.2017.04.024. Epub 2017 May 23.
PMID: 28549637DERIVEDHollis BW, Wagner CL, Howard CR, Ebeling M, Shary JR, Smith PG, Taylor SN, Morella K, Lawrence RA, Hulsey TC. Maternal Versus Infant Vitamin D Supplementation During Lactation: A Randomized Controlled Trial. Pediatrics. 2015 Oct;136(4):625-34. doi: 10.1542/peds.2015-1669.
PMID: 26416936DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carol Wagner
- Organization
- Medical University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce W. Hollis, Ph.D
Medical University of South Carolina
- PRINCIPAL INVESTIGATOR
Carol L. Wagner, MD
Medical University of South Carolina
- STUDY CHAIR
Thomas C. Hulsey, Ph.D
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
December 13, 2006
First Posted
December 15, 2006
Study Start
August 1, 2006
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
June 4, 2018
Results First Posted
June 3, 2016
Record last verified: 2018-05