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Establishing the Vitamin D Requirements During Lactation

NCT ID: NCT00412074

Last Updated: 2018-06-04

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2012-10-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

400 IU Vitamin D3 (cholecalciferol)

Intervention Type DRUG

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 (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

Group Type EXPERIMENTAL

2400 IU Vitamin D3 (cholecalciferol)

Intervention Type DRUG

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 (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

Group Type EXPERIMENTAL

6400 IU Vitamin D3 (cholecalciferol)

Intervention Type DRUG

6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

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

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Carol Wagner

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce W. Hollis, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Carol L. Wagner, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Thomas C. Hulsey, Ph.D

Role: STUDY_CHAIR

Medical University of South Carolina

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35909001 (View on PubMed)

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 Jun;17(6):493-500. doi: 10.1089/bfm.2021.0281. Epub 2022 Mar 10.

Reference Type DERIVED
PMID: 35271380 (View on PubMed)

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 May;17(5):422-428. doi: 10.1089/bfm.2021.0237. Epub 2022 Feb 23.

Reference Type DERIVED
PMID: 35196139 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32915638 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29551311 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28549637 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26416936 (View on PubMed)

Other Identifiers

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R01HD047511

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HD047511

Identifier Type: -

Identifier Source: org_study_id

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