Clincosm LogoSign in Get a demo

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

Sponsor
Medical University of South Carolina (Other)
Overall Status
Terminated
CT.gov ID
NCT04629534
Collaborator
(none)
8
Enrollment
1
Location
2
Arms
10.8
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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.
Actual Study Start Date :
May 6, 2021
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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.
Other Names:
  • 6,600 IU of cholecalciferol

    		•
    Placebo Comparator: Group B

    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.
    Other Names:
  • 600 IU of cholecalciferol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of infants with sufficient 25(OH)D stores at 3 months [3 months]

      Number of infants with 25(OH)D levels > 20 ng/mL

    2. Number of mothers with sufficient 25(OH)D stores at 3 months [3 months]

      Number of mothers with 25(OH)D levels >20 ng/mL

    3. Number of mothers with elevated calcium concentrations at 1 month [1 month]

      Number of mothers with serum calcium > 10.5 mg/dL

    4. Number of mothers with elevated calcium concentrations at month 2 [1 month]

      Number of mothers with serum calcium > 10.5 mg/dL

    5. Number of mothers with elevated calcium concentrations at month 3 [1 month]

      Number of mothers with serum calcium > 10.5 mg/dL

    6. Number of mothers with elevated urine calcium creatinine ratio at month 1 [1 month]

      Number of mothers with serum calcium > 1.0 mmol/mmol

    7. Number of mothers with elevated urine calcium creatinine ratio at month 2 [1 month]

      Number of mothers with urine calcium/creatinine ratio > 1.0 mmol/mmol

    8. Number of mothers with elevated urine calcium creatinine ratio at month 3 [1 month]

      Number of mothers with urine calcium/creatinine ratio > 1.0 mmol/mmol

    9. Number of infants with elevated calcium concentration at month 1 [1 month]

      Number of infants with serum calcium > 11.0 mg/dL

    10. Number of infants with elevated calcium concentration at month 2 [1 month]

      Number of infants with serum calcium > 11.0 mg/dL

    11. Number of infants with elevated calcium concentration at month 3 [1 month]

      Number of infants with serum calcium > 11.0 mg/dL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Days to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MUSC Shawn Jenkins Childrens Hospital Charleston South Carolina United States 29425

    Sponsors and Collaborators

    • Medical University of South Carolina

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Raechel Irons, Neonatal-Perinatal Fellow, Medical University of South Carolina
    ClinicalTrials.gov Identifier:
    NCT04629534
    Other Study ID Numbers:
    • 00099911
    First Posted:
    Nov 16, 2020
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Raechel Irons, Neonatal-Perinatal Fellow, Medical University of South Carolina
    Vitamin D
    Additional relevant MeSH terms:
    Vitamin D Deficiency
    Malnutrition
    Cholecalciferol
    Vitamin D

    Study Results

    No Results Posted as of Apr 19, 2022