Trial Outcomes & Findings for Establishing the Vitamin D Requirements During Lactation (NCT NCT00412074)

NCT ID: NCT00412074

Last Updated: 2018-06-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 460 participants
• Primary outcome timeframe: to 7 months postpartum
• Results posted on: 2018-06-04

Participant Flow

Participant milestones

Measure	Control 400 IU Vitamin D3 400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant	2400 IU Vitamin D3 (Cholecalciferol) 2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant	6400 Vitamin D3 (Cholecalciferol) 6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant
Overall Study STARTED	199	66	195
Overall Study COMPLETED	122	44	128
Overall Study NOT COMPLETED	77	22	67

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Establishing the Vitamin D Requirements During Lactation

Baseline characteristics by cohort

Measure	Control 400 IU Vitamin D3 n=199 Participants 400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant	2400 Vitamin D3 (Cholecalciferol) n=66 Participants 2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant	6400 Vitamin D3 (Cholecalciferol) n=195 Participants 6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant	Total n=460 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	199 Participants n=5 Participants	66 Participants n=7 Participants	195 Participants n=5 Participants	460 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	27.6 Years STANDARD_DEVIATION 6.2 • n=5 Participants	29.4 Years STANDARD_DEVIATION 5.3 • n=7 Participants	27.3 Years STANDARD_DEVIATION 5.9 • n=5 Participants	27.7 Years STANDARD_DEVIATION 6.0 • n=4 Participants
Sex: Female, Male Female	199 Participants n=5 Participants	66 Participants n=7 Participants	195 Participants n=5 Participants	460 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	199 participants n=5 Participants	66 participants n=7 Participants	195 participants n=5 Participants	460 participants n=4 Participants

PRIMARY outcome

Timeframe: to 7 months postpartum

Outcome measures

Measure	Control 400 IU Vitamin D3 n=122 Participants 400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant	2400 IU Vitamin D3 (Cholecalciferol) n=44 Participants 2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant	6400 Vitamin D3 (Cholecalciferol) n=128 Participants 6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant
25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery	28.5 ng/mL Standard Deviation 11.5	38.0 ng/mL Standard Deviation 55.6	55.6 ng/mL Standard Deviation 23.4

SECONDARY outcome

Timeframe: to 7 months postpartum

Percentage of subjects with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7

Outcome measures

Measure	Control 400 IU Vitamin D3 n=122 Participants 400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant	2400 IU Vitamin D3 (Cholecalciferol) n=44 Participants 2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant	6400 Vitamin D3 (Cholecalciferol) n=128 Participants 6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant
Maternal Health Status - Vitamin D Deficiency	22.95 percentage of participants	11.36 percentage of participants	4.69 percentage of participants

SECONDARY outcome

Timeframe: to 7 months of age

Population: The number of infants analyzed in each group was fewer than the number of subjects analyzed for the maternal outcomes - though blood draws were attempted for all infants at Visit 7, we were unable to obtain blood from 14 infants in the 400 IU arm, 7 infants in the 2400 IU arm, and 14 infants in the 6400 IU arm.

Percentage of infants with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7

Outcome measures

Measure	Control 400 IU Vitamin D3 n=108 Participants 400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant	2400 IU Vitamin D3 (Cholecalciferol) n=37 Participants 2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant	6400 Vitamin D3 (Cholecalciferol) n=114 Participants 6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant
Infant Health Status - Vitamin D Deficiency	2.78 percentage of infants	8.11 percentage of infants	2.63 percentage of infants

Adverse Events

Control 400 IU Vitamin D3

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

2400 IU Vitamin D3 (Cholecalciferol)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

6400 IU Vitamin D3 (Cholecalciferol)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control 400 IU Vitamin D3 n=199 participants at risk 400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant	2400 IU Vitamin D3 (Cholecalciferol) n=66 participants at risk 2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant	6400 IU Vitamin D3 (Cholecalciferol) n=195 participants at risk 6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant
General disorders Sudden Unexpected Infant Death	1.0% 2/199 • Number of events 2	0.00% 0/66	0.51% 1/195 • Number of events 1

Other adverse events

Measure	Control 400 IU Vitamin D3 n=199 participants at risk 400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant	2400 IU Vitamin D3 (Cholecalciferol) n=66 participants at risk 2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant	6400 IU Vitamin D3 (Cholecalciferol) n=195 participants at risk 6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant
General disorders Postpartum complications within one year of delivery	5.5% 11/199 • Number of events 11	9.1% 6/66 • Number of events 6	4.1% 8/195 • Number of events 8

Additional Information

Carol Wagner

Medical University of South Carolina

Phone: 18437922112

Email: wagnercl@musc.edu

Results disclosure agreements

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