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

February 17, 2023 updated by: Raechel Irons, Medical University of South Carolina

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.

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC Shawn Jenkins Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
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
Other Names:
  • 6,600 IU of cholecalciferol
Placebo Comparator: Group B
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
Other Names:
  • 600 IU of cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Infants With Sufficient 25(OH)D Stores at 3 Months
Time Frame: 3 months post enrollment
Number of infants with 25(OH)D levels > 20 ng/mL
3 months post enrollment
Number of Mothers With Sufficient 25(OH)D Stores at 3 Months
Time Frame: 3 months post enrollment
Number of mothers with 25(OH)D levels >20 ng/mL
3 months post enrollment
Number of Mothers With Elevated Calcium Concentrations at 1 Month
Time Frame: 1 month post enrollment
Number of mothers with serum calcium > 10.5 mg/dL
1 month post enrollment
Number of Mothers With Elevated Calcium Concentrations at Month 2
Time Frame: 2 months post enrollment
Number of mothers with serum calcium > 10.5 mg/dL
2 months post enrollment
Number of Mothers With Elevated Calcium Concentrations at Month 3
Time Frame: 3 months post enrollment
Number of mothers with serum calcium > 10.5 mg/dL
3 months post enrollment
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1
Time Frame: 1 month post enrollment
Number of mothers with serum calcium > 1.0 mmol/mmol
1 month post enrollment
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2
Time Frame: 2 months post enrollment
Number of mothers with urine calcium/creatinine ratio > 1.0 mmol/mmol
2 months post enrollment
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3
Time Frame: 3 months post enrollment
Number of mothers with urine calcium/creatinine ratio > 1.0 mmol/mmol
3 months post enrollment
Number of Infants With Elevated Calcium Concentration at Month 1
Time Frame: 1 month post enrollment
Number of infants with serum calcium > 11.0 mg/dL
1 month post enrollment
Number of Infants With Elevated Calcium Concentration at Month 2
Time Frame: 2 months post enrollment
Number of infants with serum calcium > 11.0 mg/dL
2 months post enrollment
Number of Infants With Elevated Calcium Concentration at Month 3
Time Frame: 3 months post enrollment
Number of infants with serum calcium > 11.0 mg/dL
3 months post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Raechel Irons, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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