NCT04629534

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

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.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 0 Days – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitamin D Deficiency
• Nutritional Deficiency

Interventions

Type	Name	Description
DRUG	High dose Cholecalciferol	Mothers in experimental group will receive 6,000 IU of vitamin D in addition to their prenatal vitamin, daily for 3 months. Infants in this group will receive placebo vitamin D drops
DRUG	Cholecalciferol	Mothers in placebo control group will receive 600 IU of vitamin D in the form of their prenatal vitamin along with placebo vitamin D. Infants of the mothers in this group will receive standard 400 IU of vitamin D

Timeline

• Start date: 2021-05-06
• Primary completion: 2021-12-31
• Completion: 2022-04-01
• First posted: 2020-11-16
• Last updated: 2023-03-15
• Results posted: 2023-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study