Vitamin d Deficiency
Conditions
Keywords
vitamin d, children, Mongolia
Brief summary
This intervention study will address the impact of vitamin D fortified milk and vitamin D supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone, academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for eczema) of Mongolian children.
Interventions
DIETARY_SUPPLEMENTMongolian milk without vitamin D
710ml per day for 49 days
DIETARY_SUPPLEMENTMongolian milk with vitamin D
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
DIETARY_SUPPLEMENTUHT milk
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
DIETARY_SUPPLEMENTMilk Substitute
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
DIETARY_SUPPLEMENTSeasonal D supplement
Deliver dosage of 13,700 IU vitamin D over 7 days
DIETARY_SUPPLEMENTDaily D supplement
Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
9 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Children in 3rd and 4th grade from selected Mongolian schools. * School selection will consider: * socioeconomic position; * geographic location; * school size; * current lunch or supplementation program; and * the interest and willingness to participate of the school's administration and faculty.
Exclusion criteria
* Allergy to milk or wheat products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Blood was analyzed at day 0 and day 49 | Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unfortified Mongolain Milk Mongolian milk without vitamin D: 710ml per day for 49 days | 101 |
| 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. | 140 |
| Fortified UHT Milk UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. | 137 |
| Daily Vitamin D Supplements Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days. | 109 |
| Seasonal Vitamin D Supplements Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days | 92 |
| Total | 579 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Final blood draw not obtained | 3 | 3 | 4 | 2 | 2 |
| Overall Study | Transferred Schools | 0 | 0 | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Unfortified Mongolain Milk | Fortified Mongolian Milk | Fortified UHT Milk | Daily Vitamin D Supplements | Seasonal Vitamin D Supplements | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 101 Participants | 140 Participants | 137 Participants | 109 Participants | 92 Participants | 579 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 51 Participants | 65 Participants | 69 Participants | 45 Participants | 41 Participants | 271 Participants |
| Sex: Female, Male Male | 50 Participants | 75 Participants | 68 Participants | 64 Participants | 51 Participants | 308 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 140 | 0 / 137 | 0 / 109 | 0 / 92 |
| other Total, other adverse events | 0 / 101 | 0 / 140 | 0 / 137 | 0 / 109 | 0 / 92 |
| serious Total, serious adverse events | 0 / 101 | 0 / 140 | 0 / 137 | 0 / 109 | 0 / 92 |
Outcome results
Primary
Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry
Time frame: Blood was analyzed at day 0 and day 49
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unfortified Mongolain Milk | Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Blood concentration on Day 0 | 8 ng/ml | Standard Deviation 4 |
| Unfortified Mongolain Milk | Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Blood concentration on Day 49 | 8 ng/ml | Standard Deviation 4 |
| Fortified Mongolian Milk | Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Blood concentration on Day 0 | 8 ng/ml | Standard Deviation 4 |
| Fortified Mongolian Milk | Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Blood concentration on Day 49 | 20 ng/ml | Standard Deviation 6 |
| Fortified UHT Milk | Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Blood concentration on Day 0 | 10 ng/ml | Standard Deviation 5 |
| Fortified UHT Milk | Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Blood concentration on Day 49 | 29 ng/ml | Standard Deviation 10 |
| Daily Vitamin D Supplements | Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Blood concentration on Day 49 | 21 ng/ml | Standard Deviation 6 |
| Daily Vitamin D Supplements | Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Blood concentration on Day 0 | 7 ng/ml | Standard Deviation 3 |
| Seasonal Vitamin D Supplements | Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Blood concentration on Day 0 | 8 ng/ml | Standard Deviation 4 |
| Seasonal Vitamin D Supplements | Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Blood concentration on Day 49 | 12 ng/ml | Standard Deviation 4 |