Clinical trial NCT00412074: Establishing the Vitamin D Requirements During Lactation
Official title: Establishing the Vitamin D Requirements During Lactation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitamin D Deficiency
Keywords: Breastfeeding
Vitamin D
Vitamin D deficiency
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2006-12-15
Enrollment: 460
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: 25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery
timeFrame: to 7 months postpartum
Secondary outcomes:
measure: Maternal Health Status - Vitamin D Deficiency
timeFrame: to 7 months postpartum
measure: Infant Health Status - Vitamin D Deficiency
timeFrame: to 7 months of age
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Bruce W. Hollis, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Carol L. Wagner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Thomas C. Hulsey, Ph.D
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.