Clinical trial NCT04629534: Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study
Official title: Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP): Maternal Diet and Vitamin D Supplementation Effects on Preterm Infants, a Randomized Control Pilot Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Nutritional Deficiency
Keywords: Vitamin D
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 8
Sex: ALL
Minimum age (years): 0
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall goal of this study is to assess maternal vitamin D status along with diet, and milk composition, and in turn, to evaluate if infant vitamin D status can be improved with increased maternal supplementation and diet education. The central hypothesis is that by maximizing maternal vitamin D status in breastfed, preterm infants (\<35 weeks), there will be an increase infant 25(OH)D status at 1,2, and 3 months of age.


Eligibility criteria: Inclusion Criteria:

* Women with documentation of fully breastfeeding who present within one month of delivery, who are 18-45 years old and in good general health will be eligible for participation.
* Infants \<35 weeks corrected gestational age at birth

Exclusion Criteria:

* NO DMI/DMII, HTN, or parathyroid disease IF thyroid issues, currently euthyroid
* Multiple gestations
* No liver disease
* No major congenital abnormalities
* No kidney disease
* No inborn errors of metabolism
* No parathyroid disease
* No disorders of calcium metabolism
* No antiepileptics
* No steroids
* No congenital heart disease
* No severe illness at birth deemed incompatible with survival

Primary outcomes:
measure: Number of Infants With Sufficient 25(OH)D Stores at 3 Months
timeFrame: 3 months post enrollment
measure: Number of Mothers With Sufficient 25(OH)D Stores at 3 Months
timeFrame: 3 months post enrollment
measure: Number of Mothers With Elevated Calcium Concentrations at 1 Month
timeFrame: 1 month post enrollment
measure: Number of Mothers With Elevated Calcium Concentrations at Month 2
timeFrame: 2 months post enrollment
measure: Number of Mothers With Elevated Calcium Concentrations at Month 3
timeFrame: 3 months post enrollment
measure: Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1
timeFrame: 1 month post enrollment
measure: Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2
timeFrame: 2 months post enrollment
measure: Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3
timeFrame: 3 months post enrollment
measure: Number of Infants With Elevated Calcium Concentration at Month 1
timeFrame: 1 month post enrollment
measure: Number of Infants With Elevated Calcium Concentration at Month 2
timeFrame: 2 months post enrollment
measure: Number of Infants With Elevated Calcium Concentration at Month 3
timeFrame: 3 months post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC Shawn Jenkins Childrens Hospital
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Raechel Irons, MD
role: PRINCIPAL_INVESTIGATOR
References: