Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Cholecalciferol

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