Trial Outcomes & Findings for Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART) (NCT NCT00920621)

NCT ID: NCT00920621

Last Updated: 2025-02-20

Results Overview

Parental report of physician diagnosis of asthma or occurrence of recurrent wheeze in the child's first 3 years of life ascertained from questionnaires administered every 3 months. \*For some variables the "negative" count incorporates "negative and indeterminate."

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 876 participants
• Primary outcome timeframe: First 3 years of life.
• Results posted on: 2025-02-20

Participant Flow

VDAART was a randomized, double-blind, placebo-controlled trial. Enrollment began October 2009 and completed follow-up January 2015 in 3 medical centers in the United Stated. 881 pregnant women age 18-39 at high risk for having children with asthma were randomized at 10-18 weeks gestation. 5 did not meet inclusion criteria and were removed.

Participant milestones

Measure	Vitamin D Treatment (Mothers) Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).	Placebo (Mothers) Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).	Vitamin D Treatment (Offspring) Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)	Placebo (Offspring) Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control"
Overall Study STARTED	440	436	440	436
Overall Study COMPLETED	386	391	405	401
Overall Study NOT COMPLETED	54	45	35	35

Reasons for withdrawal

Measure	Vitamin D Treatment (Mothers) Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).	Placebo (Mothers) Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).	Vitamin D Treatment (Offspring) Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)	Placebo (Offspring) Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control"
Overall Study Lost to Follow-up	16	17	19	21
Overall Study Fetal/neonatal deaths	16	14	16	14
Overall Study Blood sample not collected	22	14	0	0

Baseline Characteristics

Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)

Baseline characteristics by cohort

Measure	Vitamin D Treatment (Mothers) n=440 Participants Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)	Placebo (Mothers) n=436 Participants Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).	Vitamin D Treatment (Children) n=405 Participants Children of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).	Placebo (Children) n=401 Participants Children of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).	Total n=1682 Participants Total of all reporting groups
Age, Continuous	27.5 years STANDARD_DEVIATION 5.5 • n=5 Participants	27.3 years STANDARD_DEVIATION 5.6 • n=7 Participants	0 years STANDARD_DEVIATION 0 • n=5 Participants	0 years STANDARD_DEVIATION 0 • n=4 Participants	27.4 years STANDARD_DEVIATION 5.6 • n=21 Participants
Sex: Female, Male Female	440 Participants n=5 Participants	436 Participants n=7 Participants	204 Participants n=5 Participants	181 Participants n=4 Participants	1261 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	201 Participants n=5 Participants	220 Participants n=4 Participants	421 Participants n=21 Participants
Race/Ethnicity, Customized Black	190 Participants n=5 Participants	190 Participants n=7 Participants	199 Participants n=5 Participants	191 Participants n=4 Participants	770 Participants n=21 Participants
Race/Ethnicity, Customized White Hispanic	59 Participants n=5 Participants	61 Participants n=7 Participants	53 Participants n=5 Participants	51 Participants n=4 Participants	224 Participants n=21 Participants
Race/Ethnicity, Customized White non-Hispanic	114 Participants n=5 Participants	116 Participants n=7 Participants	82 Participants n=5 Participants	79 Participants n=4 Participants	391 Participants n=21 Participants
Race/Ethnicity, Customized Other	77 Participants n=5 Participants	69 Participants n=7 Participants	71 Participants n=5 Participants	80 Participants n=4 Participants	297 Participants n=21 Participants

PRIMARY outcome

Timeframe: First 3 years of life.

Population: Some measures have missing data due to collection, technical, and processing issues.

Parental report of physician diagnosis of asthma or occurrence of recurrent wheeze in the child's first 3 years of life ascertained from questionnaires administered every 3 months.

*For some variables the "negative" count incorporates "negative and indeterminate."

Outcome measures

Measure	Vitamin D Treatment n=405 Participants Children of mother's assigned 4400 IU Vitamin D	Placebo n=401 Participants Children of mother's assigned 400 IU Vitamin D.
Asthma or Recurrent Wheeze in First 3 Years of Life Children positive	98 Participants	120 Participants
Asthma or Recurrent Wheeze in First 3 Years of Life Children negative	307 Participants	281 Participants

PRIMARY outcome

Timeframe: 32-38 weeks gestation

Population: Some measures have missing data due to collection, technical, and processing issues.

Maternal serum 25-hydroxyvitamin D measurement at third trimester during pregnancy

Outcome measures

Measure	Vitamin D Treatment n=386 Participants Children of mother's assigned 4400 IU Vitamin D	Placebo n=391 Participants Children of mother's assigned 400 IU Vitamin D.
Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. 25(OH)D level of ≥ 30 ng/mL , women positive	289 Participants	133 Participants
Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. 25(OH)D level of ≥ 30 ng/mL , women negative	97 Participants	258 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Some measures have missing data due to collection, technical, and processing issues.

Child positive-specific IgE tests from blood collection at 3 year visit.

Outcome measures

Measure	Vitamin D Treatment n=3876 completed tests Children of mother's assigned 4400 IU Vitamin D	Placebo n=3651 completed tests Children of mother's assigned 400 IU Vitamin D.
Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit.	414 Positive-specific IgE tests	452 Positive-specific IgE tests

SECONDARY outcome

Timeframe: 1 year visit

Population: Some measures have missing data due to collection, technical, and processing issues.

Child serum 25-hydroxyvitamin D measurement from blood collection at 1 year visit.

Outcome measures

Measure	Vitamin D Treatment n=322 Participants Children of mother's assigned 4400 IU Vitamin D	Placebo n=309 Participants Children of mother's assigned 400 IU Vitamin D.
Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit.	29.3 ng/mL Standard Deviation 9.2	30.1 ng/mL Standard Deviation 10.8

SECONDARY outcome

Timeframe: Child's first 3 years of life.

Population: Some measures have missing data due to collection, technical, and processing issues.

Parental report of physician diagnosis of eczema with rash in typical distribution in the child's first 3 years of life ascertained from questionnaires administered every 3 months.

*For some variables the "negative" count incorporates "negative and indeterminate."

Outcome measures

Measure	Vitamin D Treatment n=405 Participants Children of mother's assigned 4400 IU Vitamin D	Placebo n=401 Participants Children of mother's assigned 400 IU Vitamin D.
Parental Report of Physician Diagnosed Eczema (With Rash) in the Child's First 3 Years of Life. Children positive	83 Participants	89 Participants
Parental Report of Physician Diagnosed Eczema (With Rash) in the Child's First 3 Years of Life. Children negative	322 Participants	312 Participants

SECONDARY outcome

Timeframe: Child's first 3 years of life.

Population: Some measures have missing data due to collection, technical, and processing issues.

Parental report of physician diagnosis of lower respiratory tract infection (LRI) in the child's first 3 years of life. LRI defined as physician diagnosed bronchitis, bronchiolitis, croup, or pneumonia ascertained from questionnaires administered every 3 months.

Outcome measures

Measure	Vitamin D Treatment n=405 Participants Children of mother's assigned 4400 IU Vitamin D	Placebo n=401 Participants Children of mother's assigned 400 IU Vitamin D.
Parental Report of Physician Diagnosis of Lower Respiratory Tract Infection in the Child's First 3 Years of Life.	222 Number of lower respiratory infections	276 Number of lower respiratory infections

SECONDARY outcome

Timeframe: Blood collection at childs' 3 year visit.

Population: Some measures have missing data due to collection, technical, and processing issues.

Child serum 25-hydroxyvitamin D measurement from blood collection at 3 year visit.

Outcome measures

Measure	Vitamin D Treatment n=289 Participants Children of mother's assigned 4400 IU Vitamin D	Placebo n=271 Participants Children of mother's assigned 400 IU Vitamin D.
Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit.	21.3 ng/mL Standard Deviation 10.4	21.5 ng/mL Standard Deviation 8.5

SECONDARY outcome

Timeframe: Child's first 3 years of life.

Population: Some measures have missing data due to collection, technical, and processing issues.

Any allergic sensitization in the child's first 3 years of life.

*For some variables the "negative" count incorporates "negative and indeterminate."

Outcome measures

Measure	Vitamin D Treatment n=278 Participants Children of mother's assigned 4400 IU Vitamin D	Placebo n=261 Participants Children of mother's assigned 400 IU Vitamin D.
Any Allergic Sensitization in the Child's First 3 Years of Life. Any sensitization	146 Participants	144 Participants
Any Allergic Sensitization in the Child's First 3 Years of Life. No sensitization	132 Participants	117 Participants

SECONDARY outcome

Timeframe: Blood collection at delivery

Population: Some measures have missing data due to collection, technical, and processing issues.

Mass Spec Vitamin D value from cord blood at delivery

Outcome measures

Measure	Vitamin D Treatment n=303 Participants Children of mother's assigned 4400 IU Vitamin D	Placebo n=316 Participants Children of mother's assigned 400 IU Vitamin D.
Mass Spec Vitamin D Value From Cord Blood at Delivery	28.2 ng/mL Standard Deviation 12.4	19.1 ng/mL Standard Deviation 9.7

SECONDARY outcome

Timeframe: 1 year

Population: Some measures have missing data due to collection, technical, and processing issues.

Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year one visit.

Outcome measures

Measure	Vitamin D Treatment n=211 Participants Children of mother's assigned 4400 IU Vitamin D	Placebo n=202 Participants Children of mother's assigned 400 IU Vitamin D.
Sphingolipid Profile sphinganine-1-phosphate	0.32 relative abundance (no units) Standard Deviation 0.10	0.32 relative abundance (no units) Standard Deviation 0.10
Sphingolipid Profile sphinganine	0.33 relative abundance (no units) Standard Deviation 0.20	0.31 relative abundance (no units) Standard Deviation 0.18
Sphingolipid Profile phosphoethanolamine	0.33 relative abundance (no units) Standard Deviation 0.13	0.34 relative abundance (no units) Standard Deviation 0.13
Sphingolipid Profile sphingosine	0.34 relative abundance (no units) Standard Deviation 0.17	0.33 relative abundance (no units) Standard Deviation 0.17
Sphingolipid Profile sphingosine-1-phosphate	0.31 relative abundance (no units) Standard Deviation 0.06	0.32 relative abundance (no units) Standard Deviation 0.06

SECONDARY outcome

Timeframe: 3 years

Population: Some measures have missing data due to collection, technical, and processing issues.

Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year three visit.

Outcome measures

Measure	Vitamin D Treatment n=179 Participants Children of mother's assigned 4400 IU Vitamin D	Placebo n=174 Participants Children of mother's assigned 400 IU Vitamin D.
Sphingolipid Profile sphinganine-1-phosphate	0.34 relative abundance (no units) Standard Deviation 0.12	0.32 relative abundance (no units) Standard Deviation 0.12
Sphingolipid Profile sphinganine	0.39 relative abundance (no units) Standard Deviation 0.20	0.37 relative abundance (no units) Standard Deviation 0.20
Sphingolipid Profile phosphoethanolamine	0.31 relative abundance (no units) Standard Deviation 0.11	0.30 relative abundance (no units) Standard Deviation 0.11
Sphingolipid Profile sphingosine	0.38 relative abundance (no units) Standard Deviation 0.19	0.37 relative abundance (no units) Standard Deviation 0.19
Sphingolipid Profile sphingosine-1-phosphate	0.31 relative abundance (no units) Standard Deviation 0.07	0.30 relative abundance (no units) Standard Deviation 0.08

SECONDARY outcome

Timeframe: 3 years

Population: Some measures have missing data due to collection, technical, and processing issues.

Genotype at the rs12936231 SNP

Outcome measures

Measure	Vitamin D Treatment n=311 Participants Children of mother's assigned 4400 IU Vitamin D	Placebo n=307 Participants Children of mother's assigned 400 IU Vitamin D.
Child 17q21 Genotype CC	93 Participants	78 Participants
Child 17q21 Genotype GC	152 Participants	161 Participants
Child 17q21 Genotype GG	66 Participants	68 Participants

SECONDARY outcome

Timeframe: Mother at 32-38 weeks gestation, Child's first 6 years of life

We extracted DNA and sequenced the bacterial 16S V4 hyper-variable region. The average number of 16S region reads sequenced per participant is provided here. Prior evidence suggests that read counts of at least 1,000 are adequate for 16S fecal microbiome profiling (Reference: Momozawa Y, et cal. Characterization of bacteria in biopsies of colon and stools by high throughput sequencing of the V2 region of bacterial 16S rRNA gene in human. PLoS One. 2011 Feb 10;6(2):e16952.)

Outcome measures

Measure	Vitamin D Treatment n=696 Samples Children of mother's assigned 4400 IU Vitamin D	Placebo n=631 Samples Children of mother's assigned 400 IU Vitamin D.
Fecal Microbiome Profile Mother at 32-38 weeks gestation	10787 read counts Standard Deviation 3534	10773 read counts Standard Deviation 2511
Fecal Microbiome Profile Child at 3-6 months	13443 read counts Standard Deviation 8624	14024 read counts Standard Deviation 9010
Fecal Microbiome Profile Child at 1 year	11709 read counts Standard Deviation 4202	11635 read counts Standard Deviation 3488
Fecal Microbiome Profile Child at 3 years	12095 read counts Standard Deviation 4733	12407 read counts Standard Deviation 4288
Fecal Microbiome Profile Child at 4 years	0 read counts Standard Deviation 0	0 read counts Standard Deviation 0
Fecal Microbiome Profile Child at 5 years	0 read counts Standard Deviation 0	0 read counts Standard Deviation 0
Fecal Microbiome Profile Child at 6 years	0 read counts Standard Deviation 0	0 read counts Standard Deviation 0

Adverse Events

Vitamin D Treatment (Mothers)

Serious events: 75 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo (Mothers)

Serious events: 77 serious events

Other events: 0 other events

Deaths: 1 deaths

Vitamin D Treatment (Offspring)

Serious events: 58 serious events

Other events: 0 other events

Deaths: 3 deaths

Placebo (Offspring)

Serious events: 52 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	Vitamin D Treatment (Mothers) n=440 participants at risk Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).	Placebo (Mothers) n=436 participants at risk Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).	Vitamin D Treatment (Offspring) n=440 participants at risk Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).	Placebo (Offspring) n=436 participants at risk Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
Pregnancy, puerperium and perinatal conditions HELLP	0.45% 2/440 • Number of events 2 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.23% 1/436 • Number of events 1 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/440 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/436 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
Pregnancy, puerperium and perinatal conditions Preeclampsia	7.7% 34/440 • Number of events 36 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	8.5% 37/436 • Number of events 38 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/440 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/436 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
General disorders Hospitalization	7.3% 32/440 • Number of events 42 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	7.3% 32/436 • Number of events 45 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/440 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/436 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
General disorders Postpartum Hospitalization	1.6% 7/440 • Number of events 10 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	1.4% 6/436 • Number of events 8 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/440 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/436 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
Pregnancy, puerperium and perinatal conditions Pre-term delivery <32 weeks gestation	0.00% 0/440 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/436 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.68% 3/440 • Number of events 5 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	1.6% 7/436 • Number of events 11 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
General disorders Maternal Death	0.00% 0/440 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.23% 1/436 • Number of events 1 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/440 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/436 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
Pregnancy, puerperium and perinatal conditions Major fetal or congenital anomaly	0.00% 0/440 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/436 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	2.3% 10/440 • Number of events 17 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	3.0% 13/436 • Number of events 14 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
General disorders NICU	0.00% 0/440 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/436 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	6.6% 29/440 • Number of events 36 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	4.1% 18/436 • Number of events 28 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
Pregnancy, puerperium and perinatal conditions Still birth or intrauterine fetal death	0.00% 0/440 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/436 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	3.0% 13/440 • Number of events 13 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	2.5% 11/436 • Number of events 11 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
Pregnancy, puerperium and perinatal conditions Neonatal demise	0.00% 0/440 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.00% 0/436 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.68% 3/440 • Number of events 3 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.	0.69% 3/436 • Number of events 3 • From the point mothers entered the study until 2 years post delivery. Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.

Other adverse events

Adverse event data not reported

Additional Information

Scott T. Weiss, MD, MS

Brigham and Women's Hospital

Phone: 617-525-2278

Email: scott.weiss@channing.harvard.edu

Results disclosure agreements

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