Trial Outcomes & Findings for Baylor Infant Biomarker of Nutrition Study (NCT NCT03996395)

NCT ID: NCT03996395

Last Updated: 2024-11-15

Results Overview

Time required to measure skin carotenoid score in 4 month olds. Units: seconds Scale: \>0 seconds Interpretation: Lower numbers indicate faster, more favorable durations for measurements. Range: 35-158 s

• Recruitment status: TERMINATED
• Target enrollment: 21 participants
• Primary outcome timeframe: 1 day each
• Results posted on: 2024-11-15

Participant Flow

Participant milestones

Measure	Infants Infants, 4-4.5 months of age at enrollment
Overall Study STARTED	21
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	Infants Infants, 4-4.5 months of age at enrollment
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	1
Overall Study Study halted due to COVID-19 pandemic.	7

Baseline Characteristics

Baylor Infant Biomarker of Nutrition Study

Baseline characteristics by cohort

Measure	Infants n=21 Participants Infants, 4-4.5 months of age at enrollment
Age, Continuous	4.14 months STANDARD_DEVIATION 0.11 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Black/African-American	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic White	6 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	10 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants
Body Mass, g	6890 grams STANDARD_DEVIATION 824 • n=5 Participants
Weight for Age, percentile	52.8 percentile STANDARD_DEVIATION 29.5 • n=5 Participants

PRIMARY outcome

Timeframe: 1 day each

Time required to measure skin carotenoid score in 4 month olds. Units: seconds Scale: >0 seconds Interpretation: Lower numbers indicate faster, more favorable durations for measurements.

Range: 35-158 s

Outcome measures

Measure	Finger n=21 Participants Time for triplicate measurement of finger skin carotenoids in 4 month olds.	Heel n=21 Participants Time for triplicate measurement of heel skin carotenoids in 4 month olds.
Duration of Skin Carotenoid Score Measurements- 4 Month Olds.	84 seconds Standard Deviation 31	71 seconds Standard Deviation 23

PRIMARY outcome

Timeframe: 1 day

Population: There are fewer blood samples than the total enrolled population due to some samples that could not be collected due to venipuncture difficulty and some families opting out of blood sampling.

Infant Plasma Total Carotenoid Concentration, 4 months.

Outcome measures

Measure	Finger n=11 Participants Time for triplicate measurement of finger skin carotenoids in 4 month olds.	Heel Time for triplicate measurement of heel skin carotenoids in 4 month olds.
Infant Plasma Carotenoid Concentration, 4 Months.	0.821 umol/L Standard Deviation 0.412	—

PRIMARY outcome

Timeframe: 7 days

Total Carotenoid Intake per day, 4 month olds, assessed by 7 day food diary

Outcome measures

Measure	Finger n=12 Participants Time for triplicate measurement of finger skin carotenoids in 4 month olds.	Heel Time for triplicate measurement of heel skin carotenoids in 4 month olds.
Total Carotenoid Intake, 4 Month Olds	225 ug/d Standard Deviation 104	—

PRIMARY outcome

Timeframe: Measurements collected at the visit held when participants were 4 months of age.

Population: all enrolled participants attending the first visit

Skin carotenoid scores in 4 month olds. Scale: 0-800 skin carotenoid score units. Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores.

Range: 14-215

Outcome measures

Measure	Finger n=21 Participants Time for triplicate measurement of finger skin carotenoids in 4 month olds.	Heel n=21 Participants Time for triplicate measurement of heel skin carotenoids in 4 month olds.
Skin Carotenoid Scores in 4 Month Olds.	92.4 skin carotenoid score units, 0-800 scale Standard Deviation 56.6	92.4 skin carotenoid score units, 0-800 scale Standard Deviation 51.4

SECONDARY outcome

Timeframe: Measurements conducted at the study visit held at either 6 months of age of 8 months of age.

Time Required for skin carotenoid score measurement, 6 and 8 month olds. Units: Seconds Scale: >0 Interpretation: Smaller durations indicate a more feasible, favorable duration Range: 37s - 133s

Outcome measures

Measure	Finger n=12 Participants Time for triplicate measurement of finger skin carotenoids in 4 month olds.	Heel n=9 Participants Time for triplicate measurement of heel skin carotenoids in 4 month olds.
Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds.	63 seconds Standard Deviation 32	62 seconds Standard Deviation 17

SECONDARY outcome

Timeframe: Measurements conducted at the study visit held at either 6 months of age of 8 months of age.

Time Required for Heel Skin Carotenoid Score Measurement, 6 and 8 Month Olds.

Outcome measures

Measure	Finger n=12 Participants Time for triplicate measurement of finger skin carotenoids in 4 month olds.	Heel n=9 Participants Time for triplicate measurement of heel skin carotenoids in 4 month olds.
Time Required for Skin Carotenoid Score Measurement, 6 and 8 Month Olds.	62 seconds Standard Deviation 17	87 seconds Standard Deviation 32

SECONDARY outcome

Timeframe: Single day at either 6 months of age of 8 months of age.

Skin carotenoid scores in 6 and 8 month olds. Units: skin carotenoid score units on a scale Scale: 0-800 Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores.

Range: 40-324

Outcome measures

Measure	Finger n=12 Participants Time for triplicate measurement of finger skin carotenoids in 4 month olds.	Heel n=9 Participants Time for triplicate measurement of heel skin carotenoids in 4 month olds.
Skin Carotenoid Scores in 6 and 8 Month Olds.	108.9 score on a scale Standard Deviation 40.5	161.0 score on a scale Standard Deviation 89.1

SECONDARY outcome

Timeframe: Single day at either 6 months of age of 8 months of age.

Skin carotenoid scores in 4 month olds. Unit: Skin Carotenoid Score Scale: 0-800 skin carotenoid score units Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores.

Range: 59-200

Outcome measures

Measure	Finger n=12 Participants Time for triplicate measurement of finger skin carotenoids in 4 month olds.	Heel n=9 Participants Time for triplicate measurement of heel skin carotenoids in 4 month olds.
Skin Carotenoid Scores in 6 and 8 Month Olds	118 score on a scale Standard Deviation 43.6	197 score on a scale Standard Deviation 128.4

SECONDARY outcome

Timeframe: 7 days prior to the visits held at 6 months of age and at 8 months of age.

Population: Due to loss to follow up, the n for these analyses is fewer than the starting population enrolled for visit 1 (4 months of age)

Total Carotenoid Intake per Day (average) Units: micrograms Scale: >0 micrograms Range: 100 - 7660

Outcome measures

Measure	Finger n=11 Participants Time for triplicate measurement of finger skin carotenoids in 4 month olds.	Heel n=9 Participants Time for triplicate measurement of heel skin carotenoids in 4 month olds.
Daily Total Carotenoid Intake, 6 and 8 Month Olds	1330 ug/d Standard Deviation 1620	3650 ug/d Standard Deviation 2700

Adverse Events

Infants

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

Nancy E. Moran, PhD

Baylor College of Medicine

Phone: 713-798-0520

Email: nancy.moran@bcm.edu

Results disclosure agreements

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