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

NCT04629534 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 00099911
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Nutritional Deficiency

Keywords

Vitamin D

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Drug: High dose Cholecalciferol

Group B

PLACEBO COMPARATOR

Drug: Cholecalciferol

Interventions

High dose Cholecalciferol DRUG

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

Also known as: 6,600 IU of cholecalciferol

Group A

Cholecalciferol DRUG

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

Also known as: 600 IU of cholecalciferol

Group B

Eligibility Criteria

• Age: 0 Days - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

MUSC Shawn Jenkins Childrens Hospital

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Malnutrition

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

Early termination leading to a small number of subjects analyzed with difficulty in enrollment. Technical issue with calculating total vitamin D intake through formula fortification and TPN along with the study drugs which can skew our data.

Results Point of Contact

• Title: Carol Wagner
• Organization: Medical University of South Carolina

wagnercl@musc.edu

843-792-5179

Study Officials

• Raechel Irons, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatal-Perinatal Fellow

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 16, 2020
• Study Start: May 6, 2021
• Primary Completion: December 31, 2021
• Study Completion: April 1, 2022
• Last Updated: March 15, 2023
• Results First Posted: March 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)