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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Vitamin D Deficiency, Nutritional Deficiency

Intervention / Treatment
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* Drug: High dose Cholecalciferol
* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Drug: High dose Cholecalciferol<br>* 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<br>* Other names: 6,600 IU of cholecalciferol;|
| Placebo Comparator: Group B<br> | Drug: Cholecalciferol<br>* 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<br>* Other names: 600 IU of cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Number of Mothers With Elevated Calcium Concentrations at 1 Month | Number of mothers with serum calcium > 10.5 mg/dL | 1 month post enrollment | 
| Number of Mothers With Elevated Calcium Concentrations at Month 2 | Number of mothers with serum calcium > 10.5 mg/dL | 2 months post enrollment | 
| Number of Mothers With Elevated Calcium Concentrations at Month 3 | Number of mothers with serum calcium > 10.5 mg/dL | 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 | 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 | 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 | 3 months post enrollment | 
| Number of Infants With Elevated Calcium Concentration at Month 1 | Number of infants with serum calcium > 11.0 mg/dL | 1 month post enrollment | 
| Number of Infants With Elevated Calcium Concentration at Month 2 | Number of infants with serum calcium > 11.0 mg/dL | 2 months post enrollment | 
| Number of Infants With Elevated Calcium Concentration at Month 3 | Number of infants with serum calcium > 11.0 mg/dL | 3 months post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D