Trial Outcomes & Findings for Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health (NCT NCT00886379)
NCT ID: NCT00886379
Last Updated: 2021-03-23
Results Overview
Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
597 participants
Primary outcome timeframe
Blood was analyzed at day 0 and day 49
Results posted on
2021-03-23
Participant Flow
Participant milestones
| Measure |
Unfortified Mongolian Milk
Mongolian milk without vitamin D: 710ml per day for 49 days
|
Fortified Mongolian Milk
Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
|
Fortified UHT Milk
UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
|
Daily Vitamin D Supplements
Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
|
Seasonal Vitamin D Supplements
Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
104
|
143
|
143
|
112
|
95
|
|
Overall Study
COMPLETED
|
101
|
140
|
137
|
109
|
92
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
6
|
3
|
3
|
Reasons for withdrawal
| Measure |
Unfortified Mongolian Milk
Mongolian milk without vitamin D: 710ml per day for 49 days
|
Fortified Mongolian Milk
Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
|
Fortified UHT Milk
UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
|
Daily Vitamin D Supplements
Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
|
Seasonal Vitamin D Supplements
Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days
|
|---|---|---|---|---|---|
|
Overall Study
Transferred Schools
|
0
|
0
|
2
|
1
|
1
|
|
Overall Study
Final blood draw not obtained
|
3
|
3
|
4
|
2
|
2
|
Baseline Characteristics
Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health
Baseline characteristics by cohort
| Measure |
Unfortified Mongolain Milk
n=101 Participants
Mongolian milk without vitamin D: 710ml per day for 49 days
|
Fortified Mongolian Milk
n=140 Participants
Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
|
Fortified UHT Milk
n=137 Participants
UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
|
Daily Vitamin D Supplements
n=109 Participants
Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
|
Seasonal Vitamin D Supplements
n=92 Participants
Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days
|
Total
n=579 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
101 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
579 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
271 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
308 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Blood was analyzed at day 0 and day 49Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry
Outcome measures
| Measure |
Unfortified Mongolain Milk
n=101 Participants
Mongolian milk without vitamin D: 710ml per day for 49 days
|
Fortified Mongolian Milk
n=140 Participants
Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
|
Fortified UHT Milk
n=137 Participants
UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
|
Daily Vitamin D Supplements
n=109 Participants
Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
|
Seasonal Vitamin D Supplements
n=92 Participants
Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days
|
|---|---|---|---|---|---|
|
Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
Blood concentration on Day 0
|
8 ng/ml
Standard Deviation 4
|
8 ng/ml
Standard Deviation 4
|
10 ng/ml
Standard Deviation 5
|
7 ng/ml
Standard Deviation 3
|
8 ng/ml
Standard Deviation 4
|
|
Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
Blood concentration on Day 49
|
8 ng/ml
Standard Deviation 4
|
20 ng/ml
Standard Deviation 6
|
29 ng/ml
Standard Deviation 10
|
21 ng/ml
Standard Deviation 6
|
12 ng/ml
Standard Deviation 4
|
Adverse Events
Unfortified Mongolain Milk
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fortified Mongolian Milk
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fortified UHT Milk
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Daily Vitamin D Supplements
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Seasonal Vitamin D Supplements
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place