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

NCT ID: NCT04629534

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2022-04-01

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.

Conditions

Vitamin D Deficiency; Nutritional Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

Group Type: EXPERIMENTAL

High dose Cholecalciferol

Intervention Type: DRUG

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

Group B

Group Type: PLACEBO_COMPARATOR

Cholecalciferol

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

6,600 IU of cholecalciferol; 600 IU of cholecalciferol

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Raechel Irons

Neonatal-Perinatal Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raechel Irons, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

MUSC Shawn Jenkins Childrens Hospital

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

00099911

Identifier Type: -

Identifier Source: org_study_id