Trial Outcomes & Findings for Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy (NCT NCT01601847)

Last Updated: 2018-06-08

Results Overview

Recurrent wheezing was defined as more than 1 episode of wheezing reported during the study period. Separate episodes were defined as occurring at least 2 weeks apart.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

300 participants

Primary outcome timeframe

up to 12 months adjusted age

Results posted on

2018-06-08

Participant Flow

Infants were recruited from participating NICUs, special care nurseries, and well-baby nurseries.

If all eligibility labs were not available from routine clinical care, parents were consented prior to obtaining the remaining eligibility labs. If those post-consent laboratory results made the infant ineligible, they were not randomized.

Participant milestones

Participant milestones
Measure	Sustained Infants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake Cholecalciferol: Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.	Diet-Limited Infants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day Cholecalciferol: Once the dietary intake of vitamin D has exceeded 200 IU/Day from formula or fortifiers, the infants will receive placebo until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.
Overall Study STARTED	153	147
Overall Study COMPLETED	140	137
Overall Study NOT COMPLETED	13	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Sustained Infants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake Cholecalciferol: Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.	Diet-Limited Infants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day Cholecalciferol: Once the dietary intake of vitamin D has exceeded 200 IU/Day from formula or fortifiers, the infants will receive placebo until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.
Overall Study Death	1	0
Overall Study Withdrawal by Subject	11	7
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

One infant withdrew before completion of all baseline data forms.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sustained n=153 Participants Infants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake Cholecalciferol: Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.	Diet-Limited n=147 Participants Infants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day Cholecalciferol: Once the dietary intake of vitamin D has exceeded 200 IU/Day from formula or fortifiers, the infants will receive placebo until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.	Total n=300 Participants Total of all reporting groups
Age, Categorical <=18 years	153 Participants n=153 Participants	147 Participants n=147 Participants	300 Participants n=300 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=153 Participants	0 Participants n=147 Participants	0 Participants n=300 Participants
Age, Categorical >=65 years	0 Participants n=153 Participants	0 Participants n=147 Participants	0 Participants n=300 Participants
Sex: Female, Male Female	76 Participants n=153 Participants • One infant withdrew before completion of all baseline data forms.	57 Participants n=146 Participants • One infant withdrew before completion of all baseline data forms.	133 Participants n=299 Participants • One infant withdrew before completion of all baseline data forms.
Sex: Female, Male Male	77 Participants n=153 Participants • One infant withdrew before completion of all baseline data forms.	89 Participants n=146 Participants • One infant withdrew before completion of all baseline data forms.	166 Participants n=299 Participants • One infant withdrew before completion of all baseline data forms.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=153 Participants	0 Participants n=147 Participants	0 Participants n=300 Participants
Race (NIH/OMB) Asian	0 Participants n=153 Participants	0 Participants n=147 Participants	0 Participants n=300 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=153 Participants	0 Participants n=147 Participants	0 Participants n=300 Participants
Race (NIH/OMB) Black or African American	153 Participants n=153 Participants	147 Participants n=147 Participants	300 Participants n=300 Participants
Race (NIH/OMB) White	0 Participants n=153 Participants	0 Participants n=147 Participants	0 Participants n=300 Participants
Race (NIH/OMB) More than one race	0 Participants n=153 Participants	0 Participants n=147 Participants	0 Participants n=300 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=153 Participants	0 Participants n=147 Participants	0 Participants n=300 Participants
Gestational age at birth	33.00 weeks n=153 Participants	33.50 weeks n=147 Participants	33.14 weeks n=300 Participants
Birth weight	1.84 kg n=153 Participants • One infant was withdrawn before all baseline/inpatient data capture forms were completed.	1.96 kg n=146 Participants • One infant was withdrawn before all baseline/inpatient data capture forms were completed.	1.87 kg n=299 Participants • One infant was withdrawn before all baseline/inpatient data capture forms were completed.
Multiple birth (twins and triplets)	58 Participants n=153 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.	38 Participants n=146 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.	96 Participants n=299 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.
Antenatal steroids	82 Participants n=153 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.	78 Participants n=146 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.	160 Participants n=299 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.
History of ventilator support	27 Participants n=153 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.	26 Participants n=146 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.	53 Participants n=299 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.
History of oxygen administration	66 Participants n=153 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.	53 Participants n=146 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.	119 Participants n=299 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.
Receiving maternal breast milk at randomization	107 Participants n=153 Participants	104 Participants n=147 Participants	211 Participants n=300 Participants
Discharge season (Oct-March)	69 Participants n=153 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.	67 Participants n=146 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.	136 Participants n=299 Participants • Measure Analysis Population Description: One infant withdrew before completion of all baseline data forms.
Calcium (mg/dl)	9.5 mg/dl n=153 Participants	9.5 mg/dl n=147 Participants	9.5 mg/dl n=300 Participants
Phosphorus (mg/dl)	7.0 mg/dl n=153 Participants	6.9 mg/dl n=147 Participants	7.0 mg/dl n=300 Participants
Alkaline phosphatase (U/L)	268 U/L n=153 Participants	257 U/L n=147 Participants	263 U/L n=300 Participants
Total circulating 25(OH)D (ng/ml)	19.1 ng/ml n=153 Participants	21.0 ng/ml n=147 Participants	20.2 ng/ml n=300 Participants

PRIMARY outcome

Timeframe: up to 12 months adjusted age

Population: Infants that were withdrawn, completely lost to follow-up, who died, or for whom recurrent wheezing status was indeterminate due to a missing 12 month visit (n=8) were not included in the primary analysis.

Recurrent wheezing was defined as more than 1 episode of wheezing reported during the study period. Separate episodes were defined as occurring at least 2 weeks apart.

Outcome measures

Outcome measures
Measure	Sustained n=135 Participants Infants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake Cholecalciferol: Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.	Diet-Limited n=134 Participants Infants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day Cholecalciferol: Once the dietary intake of vitamin D has exceeded 200 IU/Day from formula or fortifiers, the infants will receive placebo until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.
Number of Infants With Recurrent Wheezing	42 Participants	56 Participants

SECONDARY outcome

Timeframe: Measured at the 12 month adjusted age visit

Population: Positive result is \>0.35 U/L PAU/l

Measured using the Phadiatop Infant IgE panel

Outcome measures

Outcome measures
Measure	Sustained n=116 Participants Infants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake Cholecalciferol: Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.	Diet-Limited n=112 Participants Infants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day Cholecalciferol: Once the dietary intake of vitamin D has exceeded 200 IU/Day from formula or fortifiers, the infants will receive placebo until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.
Number With Infants With Allergic Sensitization as Measured by the PhadiaTop Infant Assay	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Measured at the 12 month adjusted age visit

Population: Bone density was not performed if (1) infant could not come to the clinic for their 12 month visit and the visit was done in the home (2) they missed their 12 month visit (3) the ultrasound was under repair, or (4) infant could not participate with the ultrasound to get a sufficient quality reading.

Measured by bone speed of sound (ultrasound)

Outcome measures

Outcome measures
Measure	Sustained n=105 Participants Infants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake Cholecalciferol: Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.	Diet-Limited n=107 Participants Infants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day Cholecalciferol: Once the dietary intake of vitamin D has exceeded 200 IU/Day from formula or fortifiers, the infants will receive placebo until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.
Bone Density	3155 m/s Interval 2908.0 to 3409.0	3149 m/s Interval 2898.0 to 3351.0

Adverse Events

Sustained

Serious events: 36 serious events

Other events: 123 other events

Deaths: 1 deaths

Diet-Limited

Serious events: 38 serious events

Other events: 123 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Sustained n=153 participants at risk Infants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake Cholecalciferol: Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.	Diet-Limited n=147 participants at risk Infants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day Cholecalciferol: Once the dietary intake of vitamin D has exceeded 200 IU/Day from formula or fortifiers, the infants will receive placebo until they are 6 months of age adjusted for prematurity. Exclusively breastfed infants receive 400 IU of vitamin D daily as needed beyond 6 months adjusted age for the duration of the study.
Respiratory, thoracic and mediastinal disorders Asthma or Wheezing	24.8% 38/153 • Number of events 65 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	24.5% 36/147 • Number of events 60 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.
Infections and infestations Upper Respiratory Infection	54.9% 84/153 • Number of events 163 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	53.1% 78/147 • Number of events 155 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.
Infections and infestations Lower Respiratory Infection	17.6% 27/153 • Number of events 39 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	15.6% 23/147 • Number of events 31 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.
Gastrointestinal disorders Constipation	4.6% 7/153 • Number of events 7 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	6.1% 9/147 • Number of events 9 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.
Gastrointestinal disorders Diarrhea, non-infectious	2.6% 4/153 • Number of events 4 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	10.9% 16/147 • Number of events 16 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.
Gastrointestinal disorders Vomiting, non-infectious	5.9% 9/153 • Number of events 11 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	12.9% 19/147 • Number of events 21 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.
Gastrointestinal disorders GI, not otherwise specified	5.2% 8/153 • Number of events 10 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	11.6% 17/147 • Number of events 17 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.
Endocrine disorders Elevated alkaline phosphatase	8.5% 13/153 • Number of events 14 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	8.2% 12/147 • Number of events 14 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.
Endocrine disorders Hypercalcemia	17.6% 27/153 • Number of events 27 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	17.0% 25/147 • Number of events 29 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.
Infections and infestations GI Infection	8.5% 13/153 • Number of events 15 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	9.5% 14/147 • Number of events 17 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.
Infections and infestations Infection, not otherwise specified	28.8% 44/153 • Number of events 63 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	34.7% 51/147 • Number of events 68 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.
Blood and lymphatic system disorders Anemia	6.5% 10/153 • Number of events 10 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	3.4% 5/147 • Number of events 5 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.
Skin and subcutaneous tissue disorders Rash	23.5% 36/153 • Number of events 47 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	28.6% 42/147 • Number of events 56 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.
General disorders Other AE	12.4% 19/153 • Number of events 22 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.	15.0% 22/147 • Number of events 25 • Up to 12 months adjusted age Study personnel screened for adverse events at each study visit. Adverse event categories/organ systems are not mutually exclusive (for instance, an AE could be coded under both respiratory and infectious categories). All significant associated symptoms/findings were coded for each (S)AE. 36 patients in the Sustained arm had a total of 44 SAEs; 38 patients in the Diet-Limited arm had a total of 56 SAEs. Some patients experienced more than one SAE.

Additional Information

Dr. Anna Maria Hibbs

Case Western Reserve University

Phone: 216-844-3387

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place