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

Primary Purpose

Vitamin D Deficiency, Nutritional Deficiency

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

High dose Cholecalciferol

Cholecalciferol

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring Vitamin D

Eligibility Criteria

0 Days - 45 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

MUSC Shawn Jenkins Childrens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

Number of Infants With Sufficient 25(OH)D Stores at 3 Months

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

Number of Mothers With Sufficient 25(OH)D Stores at 3 Months

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

Number of Mothers With Elevated Calcium Concentrations at 1 Month

Number of mothers with serum calcium > 10.5 mg/dL

Number of Mothers With Elevated Calcium Concentrations at Month 2

Number of mothers with serum calcium > 10.5 mg/dL

Number of Mothers With Elevated Calcium Concentrations at Month 3

Number of mothers with serum calcium > 10.5 mg/dL

Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1

Number of mothers with serum calcium > 1.0 mmol/mmol

Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2

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

Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3

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

Number of Infants With Elevated Calcium Concentration at Month 1

Number of infants with serum calcium > 11.0 mg/dL

Number of Infants With Elevated Calcium Concentration at Month 2

Number of infants with serum calcium > 11.0 mg/dL

Number of Infants With Elevated Calcium Concentration at Month 3

Number of infants with serum calcium > 11.0 mg/dL

Secondary Outcome Measures

Full Information

NCT ID

NCT04629534

First Posted

November 10, 2020

Last Updated

February 17, 2023

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT04629534

Brief Title

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

Acronym

MoMO PIP

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Terminated

Why Stopped

low enrollment, lack of funding

Study Start Date

May 6, 2021 (Actual)

Primary Completion Date

December 31, 2021 (Actual)

Study Completion Date

April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency, Nutritional Deficiency

Keywords

Vitamin D

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Title

Group B

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

High dose Cholecalciferol

Other Intervention Name(s)

6,600 IU of cholecalciferol

Intervention Description

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

Intervention Name(s)

Cholecalciferol

Other Intervention Name(s)

600 IU of cholecalciferol

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Infants With Sufficient 25(OH)D Stores at 3 Months

Description

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

Time Frame

3 months post enrollment

Title

Number of Mothers With Sufficient 25(OH)D Stores at 3 Months

Description

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

Time Frame

3 months post enrollment

Title

Number of Mothers With Elevated Calcium Concentrations at 1 Month

Description

Number of mothers with serum calcium > 10.5 mg/dL

Time Frame

1 month post enrollment

Title

Number of Mothers With Elevated Calcium Concentrations at Month 2

Description

Number of mothers with serum calcium > 10.5 mg/dL

Time Frame

2 months post enrollment

Title

Number of Mothers With Elevated Calcium Concentrations at Month 3

Description

Number of mothers with serum calcium > 10.5 mg/dL

Time Frame

3 months post enrollment

Title

Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1

Description

Number of mothers with serum calcium > 1.0 mmol/mmol

Time Frame

1 month post enrollment

Title

Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2

Description

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

Time Frame

2 months post enrollment

Title

Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3

Description

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

Time Frame

3 months post enrollment

Title

Number of Infants With Elevated Calcium Concentration at Month 1

Description

Number of infants with serum calcium > 11.0 mg/dL

Time Frame

1 month post enrollment

Title

Number of Infants With Elevated Calcium Concentration at Month 2

Description

Number of infants with serum calcium > 11.0 mg/dL

Time Frame

2 months post enrollment

Title

Number of Infants With Elevated Calcium Concentration at Month 3

Description

Number of infants with serum calcium > 11.0 mg/dL

Time Frame

3 months post enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Days

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raechel Irons, MD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

MUSC Shawn Jenkins Childrens Hospital

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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