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

Phase 4

Terminated

• Conditions: Vitamin D Deficiency; Nutritional Deficiency
• Interventions: Drug: High dose Cholecalciferol; Drug: Cholecalciferol

• Registration Number: NCT04629534
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-10
• Study First Posted: 2020-11-16
• Study Start: 2021-05-06
• Primary Completion: 2021-12-31
• Study Completion: 2022-04-01
• Results First Submitted: 2022-06-01
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-17
• Last Update Submitted: 2023-02-17
• Results First Posted: 2023-03-15
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	High dose Cholecalciferol	-
Group B	Cholecalciferol	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

MUSC Shawn Jenkins Childrens Hospital; 🇺🇸 Charleston, South Carolina, United States