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

Phase 4TerminatedNCT04629534

Medical University of South Carolina8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Vitamin D Deficiency Nutritional Deficiency

Interventions

High dose CholecalciferolDRUG

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

CholecalciferolDRUG

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

Eligibility

Sex: ALLMin age: 0 DaysMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

MUSC Shawn Jenkins Childrens Hospital

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

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

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

Time frame: 3 months post enrollment

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

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

Time frame: 3 months post enrollment

Number of Mothers With Elevated Calcium Concentrations at 1 Month

Number of mothers with serum calcium \> 10.5 mg/dL

Time frame: 1 month post enrollment

Number of Mothers With Elevated Calcium Concentrations at Month 2

Number of mothers with serum calcium \> 10.5 mg/dL

Time frame: 2 months post enrollment

Number of Mothers With Elevated Calcium Concentrations at Month 3

Number of mothers with serum calcium \> 10.5 mg/dL

Time frame: 3 months post enrollment

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

Number of mothers with serum calcium \> 1.0 mmol/mmol

Time frame: 1 month post enrollment

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

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

Time frame: 2 months post enrollment

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

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

Time frame: 3 months post enrollment

Data from ClinicalTrials.gov

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