Trial Outcomes & Findings for Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study (NCT NCT04629534)

NCT ID: NCT04629534

Last Updated: 2023-03-15

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 8 participants
• Primary outcome timeframe: 3 months post enrollment
• Results posted on: 2023-03-15

Participant Flow

This study contained dyads of mother's and their newborn infants. Double-blinded control randomized study

This study involves mother and infant dyads. There were 8 individual participants enrolled onto the study. 4 mothers and 4 infants which is equivalent to 4 dyads. Group A had 2 dyads (4 individual participants). Group B also had 2 dyads (4 individual participants) However, if an infant became ineligible but mother still qualified, she could remain in the study separately. The participant flow reflects the individual participants.

Participant milestones

Measure	Group A 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 of these mothers will receive placebo drops.	Group B 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 these mothers will receive standard 400 IU of vitamin D drops.
Overall Study STARTED	4	4
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Group A 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 of these mothers will receive placebo drops.	Group B 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 these mothers will receive standard 400 IU of vitamin D drops.
Overall Study Physician Decision	1	0
Overall Study Protocol Violation	0	2

Baseline Characteristics

Means reflect only mother's ages

Baseline characteristics by cohort

Measure	Group A n=4 Participants 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.	Group B n=4 Participants 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.	Total n=8 Participants Total of all reporting groups
Age, Continuous Mothers	28.5 years n=2 Participants • Means reflect only mother's ages	24.5 years n=2 Participants • Means reflect only mother's ages	27 years n=4 Participants • Means reflect only mother's ages
Age, Customized Infants	28.5 weeks n=2 Participants • moms are measured in years and baby's are measured in weeks of age at birth	30 weeks n=2 Participants • moms are measured in years and baby's are measured in weeks of age at birth	29.25 weeks n=4 Participants • moms are measured in years and baby's are measured in weeks of age at birth
Sex: Female, Male Mothers · Female	2 Participants n=2 Participants • For analyzing this population I separated out mothers and infants.	2 Participants n=2 Participants • For analyzing this population I separated out mothers and infants.	4 Participants n=4 Participants • For analyzing this population I separated out mothers and infants.
Sex: Female, Male Mothers · Male	0 Participants n=2 Participants • For analyzing this population I separated out mothers and infants.	0 Participants n=2 Participants • For analyzing this population I separated out mothers and infants.	0 Participants n=4 Participants • For analyzing this population I separated out mothers and infants.
Sex: Female, Male Infants · Female	1 Participants n=2 Participants • For analyzing this population I separated out mothers and infants.	1 Participants n=2 Participants • For analyzing this population I separated out mothers and infants.	2 Participants n=4 Participants • For analyzing this population I separated out mothers and infants.
Sex: Female, Male Infants · Male	1 Participants n=2 Participants • For analyzing this population I separated out mothers and infants.	1 Participants n=2 Participants • For analyzing this population I separated out mothers and infants.	2 Participants n=4 Participants • For analyzing this population I separated out mothers and infants.
Race (NIH/OMB) Mothers · American Indian or Alaska Native	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=4 Participants • Mothers and infants were analyzed separately
Race (NIH/OMB) Mothers · Asian	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=4 Participants • Mothers and infants were analyzed separately
Race (NIH/OMB) Mothers · Native Hawaiian or Other Pacific Islander	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=4 Participants • Mothers and infants were analyzed separately
Race (NIH/OMB) Mothers · Black or African American	1 Participants n=2 Participants • Mothers and infants were analyzed separately	1 Participants n=2 Participants • Mothers and infants were analyzed separately	2 Participants n=4 Participants • Mothers and infants were analyzed separately
Race (NIH/OMB) Mothers · White	1 Participants n=2 Participants • Mothers and infants were analyzed separately	1 Participants n=2 Participants • Mothers and infants were analyzed separately	2 Participants n=4 Participants • Mothers and infants were analyzed separately
Race (NIH/OMB) Mothers · More than one race	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=4 Participants • Mothers and infants were analyzed separately
Race (NIH/OMB) Mothers · Unknown or Not Reported	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=4 Participants • Mothers and infants were analyzed separately
Race (NIH/OMB) Infants · American Indian or Alaska Native	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=4 Participants • Mothers and infants were analyzed separately
Race (NIH/OMB) Infants · Asian	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=4 Participants • Mothers and infants were analyzed separately
Race (NIH/OMB) Infants · Native Hawaiian or Other Pacific Islander	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=4 Participants • Mothers and infants were analyzed separately
Race (NIH/OMB) Infants · Black or African American	1 Participants n=2 Participants • Mothers and infants were analyzed separately	1 Participants n=2 Participants • Mothers and infants were analyzed separately	2 Participants n=4 Participants • Mothers and infants were analyzed separately
Race (NIH/OMB) Infants · White	1 Participants n=2 Participants • Mothers and infants were analyzed separately	1 Participants n=2 Participants • Mothers and infants were analyzed separately	2 Participants n=4 Participants • Mothers and infants were analyzed separately
Race (NIH/OMB) Infants · More than one race	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=4 Participants • Mothers and infants were analyzed separately
Race (NIH/OMB) Infants · Unknown or Not Reported	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=2 Participants • Mothers and infants were analyzed separately	0 Participants n=4 Participants • Mothers and infants were analyzed separately
Region of Enrollment United States	4 participants n=4 Participants	4 participants n=4 Participants	8 participants n=8 Participants

PRIMARY outcome

Timeframe: 3 months post enrollment

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

Outcome measures

Measure	Group A n=1 Participants 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.	Group B n=1 Participants 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.
Number of Infants With Sufficient 25(OH)D Stores at 3 Months	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 3 months post enrollment

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

Outcome measures

Measure	Group A n=1 Participants 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.	Group B n=2 Participants 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.
Number of Mothers With Sufficient 25(OH)D Stores at 3 Months	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 1 month post enrollment

Number of mothers with serum calcium > 10.5 mg/dL

Outcome measures

Measure	Group A n=1 Participants 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.	Group B n=2 Participants 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.
Number of Mothers With Elevated Calcium Concentrations at 1 Month	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 months post enrollment

Number of mothers with serum calcium > 10.5 mg/dL

Outcome measures

Measure	Group A n=1 Participants 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.	Group B n=2 Participants 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.
Number of Mothers With Elevated Calcium Concentrations at Month 2	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 3 months post enrollment

Number of mothers with serum calcium > 10.5 mg/dL

Outcome measures

Measure	Group A n=1 Participants 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.	Group B n=2 Participants 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.
Number of Mothers With Elevated Calcium Concentrations at Month 3	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 1 month post enrollment

Number of mothers with serum calcium > 1.0 mmol/mmol

Outcome measures

Measure	Group A n=1 Participants 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.	Group B n=2 Participants 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.
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 months post enrollment

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

Outcome measures

Measure	Group A n=1 Participants 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.	Group B n=2 Participants 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.
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 3 months post enrollment

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

Outcome measures

Measure	Group A n=1 Participants 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.	Group B n=2 Participants 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.
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 1 month post enrollment

Number of infants with serum calcium > 11.0 mg/dL

Outcome measures

Measure	Group A n=1 Participants 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.	Group B n=2 Participants 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.
Number of Infants With Elevated Calcium Concentration at Month 1	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 months post enrollment

Number of infants with serum calcium > 11.0 mg/dL

Outcome measures

Measure	Group A n=1 Participants 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.	Group B n=1 Participants 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.
Number of Infants With Elevated Calcium Concentration at Month 2	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 3 months post enrollment

Number of infants with serum calcium > 11.0 mg/dL

Outcome measures

Measure	Group A n=1 Participants 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.	Group B n=1 Participants 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.
Number of Infants With Elevated Calcium Concentration at Month 3	0 Participants	0 Participants

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carol Wagner

Medical University of South Carolina

Phone: 843-792-5179

Email: wagnercl@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place