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

Medical University of South Carolina (MUSC)

Status and phase: Terminated; Phase 4

Conditions: Vitamin D Deficiency; Nutritional Deficiency

Treatments: Drug: Cholecalciferol; Drug: High dose Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT04629534

00099911

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: Under 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

Group A

Experimental group

Treatment:

Drug: High dose Cholecalciferol

Group B

Placebo Comparator group

Treatment:

Drug: Cholecalciferol