Establishing the Vitamin D Requirements During Lactation

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ClinicalTrials.gov Identifier: NCT00412074

Recruitment Status : Completed

First Posted : December 15, 2006

Results First Posted : June 3, 2016

Last Update Posted : June 4, 2018

Sponsor:

Collaborators:

National Institutes of Health (NIH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party):

Carol Wagner, Medical University of South Carolina

Study Description

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

Condition or disease	Intervention/treatment	Phase
Vitamin D Deficiency	Drug: 400 IU Vitamin D3 (cholecalciferol) Drug: 2400 IU Vitamin D3 (cholecalciferol) Drug: 6400 IU Vitamin D3 (cholecalciferol)	Phase 3

Detailed Description:

Mothers from two study sites at different latitudes will be randomized to receive 1 of 3 treatment regimes of vitD3. Mothers, lactating or nonlactating controls will be randomized to either Group A: standard treatment(400 IU D3/d), Group B: (2,400 IU D3/d), or Group C: (6,400 IU D3/d. Infants of mothers randomized to Group A will receive 400 IU D3/d (recommended practice) and infants of mothers assigned to Groups B or C will receive placebo. On 2/5/2009, the protocol was amended and the Group B arm was dropped; infants of active subjects randomized to Group B as of 2/5/2009 were put on open label treatment (400 IU D3/d) through study completion. Newly enrolled subjects after this date were randomized to Group A or Group C only.

By measuring an array of indicators,calcium homeostasis and skeletal remodeling in the postpartum mother and the breastfeeding infant will be monitored. Through this study, the prevalence of vitD deficiency in the breastfeeding dyad and the utility of maternal therapeutic intervention with VitD3 will be assessed.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	460 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Establishing the Vitamin D Requirements During Lactation
Study Start Date :	August 2006
Actual Primary Completion Date :	October 2012
Actual Study Completion Date :	October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding Vitamin D Vitamin D Deficiency

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Control 400 IU vitamin D3 400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad	Drug: 400 IU Vitamin D3 (cholecalciferol) 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant
Experimental: 2400 IU vitamin D3 (cholecalciferol) 2400 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	Drug: 2400 IU Vitamin D3 (cholecalciferol) 2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
Experimental: 6400 IU vitamin D3 (cholecalciferol) 6400 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	Drug: 6400 IU Vitamin D3 (cholecalciferol) 6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant

Outcome Measures

Primary Outcome Measures :

25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery [ Time Frame: to 7 months postpartum ]

Secondary Outcome Measures :

Maternal Health Status - Vitamin D Deficiency [ Time Frame: to 7 months postpartum ]
Percentage of subjects with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7
Infant Health Status - Vitamin D Deficiency [ Time Frame: to 7 months of age ]
Percentage of infants with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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

Contacts and Locations

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): NCT00412074

Locations

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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

National Institutes of Health (NIH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

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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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Andrews 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 Mar 10. doi: 10.1089/bfm.2021.0281. [Epub ahead of print]

Pouch 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 Feb 23. doi: 10.1089/bfm.2021.0237. [Epub ahead of print]

Wagner 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.

Bell 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.

Sen 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.

Hollis 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. Erratum in: Pediatrics. 2019 Jul;144(1):.

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Responsible Party:	Carol Wagner, Professor of Pediatrics, Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00412074
Other Study ID Numbers:	HD047511 R01HD047511 ( U.S. NIH Grant/Contract )
First Posted:	December 15, 2006 Key Record Dates
Results First Posted:	June 3, 2016
Last Update Posted:	June 4, 2018
Last Verified:	May 2018

Keywords provided by Carol Wagner, Medical University of South Carolina:


Breastfeeding Vitamin D Vitamin D deficiency

Additional relevant MeSH terms:

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Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamin D Ergocalciferols	Cholecalciferol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents

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