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

Vitamin D Deficiency Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04629534
• Other study ID #: 00099911
• Status: Terminated
• Phase: Phase 4
• Start date: May 6, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: February 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Nutritional Deficiency
• Vitamin D Deficiency

Intervention

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. Infants in this group will receive placebo vitamin D drops
• 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. Infants of the mothers in this group will receive standard 400 IU of vitamin D

Locations

Country	Name	City	State
United States	MUSC Shawn Jenkins Childrens Hospital	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

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