Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04629534
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Raechel Irons, Medical University of South Carolina

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Vitamin D Deficiency Nutritional Deficiency Drug: High dose Cholecalciferol Drug: Cholecalciferol Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: 600 IU of cholecalciferol


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of infants with sufficient 25(OH)D stores at 3 months [ Time Frame: 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 [ Time Frame: 3 months ]
    Number of mothers with 25(OH)D levels >20 ng/mL

  3. Number of mothers with elevated calcium concentrations at 1 month [ Time Frame: 1 month ]
    Number of mothers with serum calcium > 10.5 mg/dL

  4. Number of mothers with elevated calcium concentrations at month 2 [ Time Frame: 1 month ]
    Number of mothers with serum calcium > 10.5 mg/dL

  5. Number of mothers with elevated calcium concentrations at month 3 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 month ]
    Number of infants with serum calcium > 11.0 mg/dL

  10. Number of infants with elevated calcium concentration at month 2 [ Time Frame: 1 month ]
    Number of infants with serum calcium > 11.0 mg/dL

  11. Number of infants with elevated calcium concentration at month 3 [ Time Frame: 1 month ]
    Number of infants with serum calcium > 11.0 mg/dL


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629534


Contacts
Layout table for location contacts
Contact: Raechel Irons, MD 843-792-1047 ironsr@musc.edu

Locations
Layout table for location information
United States, South Carolina
MUSC Shawn Jenkins Childrens Hospital Recruiting
Charleston, South Carolina, United States, 29425
Contact: MUSC Shawn Jenkins C Hospital         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Layout table for investigator information
Principal Investigator: Raechel Irons, MD Medical University of South Carolina
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Raechel Irons, Neonatal-Perinatal Fellow, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04629534    
Other Study ID Numbers: 00099911
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raechel Irons, Medical University of South Carolina:
Vitamin D
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin D Deficiency
Malnutrition
Avitaminosis
Deficiency Diseases
Nutrition Disorders
Cholecalciferol
 Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Bone Density Conservation Agents