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This study is conducted in two phases. At the first phase, the prevalence of vitamin D insufficiency in primary school-children in Tehran is determined during the cold seasons of 2008. Then, the efficacy of calcium-vitamin D-fortified milk, -orange juice and supplement is compared in six selected primary schools.
At the first step, serum 25-(OH)D, PTH(parathyroid hormone), osteocalcin, bone alkaline phosphatase, calcium, phosphorous, and magnesium is evaluated. Anthropometric and dietary intake data is also collected. In the second phase, we have 6 experimental groups: (1) plain milk; (2) calcium-vitamin D-fortified milk (containing 500 mg Ca and 100 IU vitamin D/200 mL package); (3) plain orange juice; (4) fortified orange juice containing equal amounts of calcium and vitamin D as fortified milk; (5) calcium-vitamin D supplement (500 mg calcium and 200 IU vitamin D); and (6) placebo. Each group consists of 40-60 children (9-11 years) from both sexes. All above-mentioned biochemical, anthropometric and dietary intake data is collected both in the beginning and in the end of interventional period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fortified milk | Experimental | daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 mL |
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| plain milk | Active Comparator | daily intake of 200 mL plain milk |
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| fortified orange juice | Experimental | daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium |
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| plane juice | Active Comparator | subjects receiving plain orange juice |
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| vitamin D-Ca supplement | Experimental | Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D |
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| Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fortified milk | Dietary Supplement | daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 ml package for 10 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group | Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method. | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tirang R. Neyestani, Ph.D. | National Nutrition and Food Technology Research Institute, P.O. Box 19295-4741 | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fortified Milk | daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL |
| FG001 | Plain Milk | daily intake of 200 mL plain milk |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Subjects receiving daily placebo containing 1g starch
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| plain milk | Dietary Supplement | daily intake of 200 ml plain milk |
|
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| fortified orange juice | Dietary Supplement | daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium/250 ml package |
|
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| plain orange juice | Dietary Supplement | daily intake of 250 ml plain orange juice |
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| calcium-vitamin D supplement | Dietary Supplement | daily calcium-vitamin D supplement (500 mg calcium + 200 IU vitamin D) |
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| Placebo | Dietary Supplement | daily placebo |
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| FG002 | Fortified Orange Juice | daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium |
| FG003 | Plain Juice | subjects receiving plain orange juice |
| FG004 | Vitamin D-Calcium Supplement | Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D |
| FG005 | Placebo | Subjects receiving daily placebo containing 1 g starch |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fortified Milk | daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL |
| BG001 | Plain Milk | daily intake of 200 mL plain milk |
| BG002 | Fortified Orange Juice | daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium |
| BG003 | Plain Juice | subjects receiving plain orange juice |
| BG004 | Vitamin D-Calcium Supplement | Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D |
| BG005 | Placebo | Subjects receiving daily placebo containing 1 g starch |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Serum levels of 25(OH)D | Anthropometric and laboratory assessments were carried out at the beginning and at the end of the intervention. In order to perform blood analyses, 3mL of venous blood was taken from all the participants. Laboratory tests included hemoglobin, hematocrit, serum levels of 25(OH)D, iPTH, osteocalcin, bone-specific alkaline phosphatase (BAP), calcium, phosphorous, magnesium, total protein and albumin. | Mean | Standard Deviation | nmol/L |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group | Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method. | Posted | Mean | Standard Deviation | nmol/L | 10 weeks |
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3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fortified Milk | daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL | 0 | 104 | 0 | 104 | ||
| EG001 | Plain Milk | daily intake of 200 mL plain milk | 0 | 95 | 0 | 95 | ||
| EG002 | Fortified Orange Juice | daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium | 0 | 102 | 0 | 102 | ||
| EG003 | Plain Juice | subjects receiving plain orange juice | 0 | 96 | 0 | 96 | ||
| EG004 | Vitamin D-Calcium Supplement | Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D | 0 | 103 | 0 | 103 | ||
| EG005 | Placebo | Subjects receiving daily placebo containing 1 g starch | 0 | 85 | 0 | 85 |
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Because of very cold winter, it was not possible to extend the intervention period to 12 weeks or longer. Moreover, it was impossible to fortify the foodstuffs with more than 50% of RDA(recommended daily allowance) because of legal problems.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tirang R. Neyestani | National Nutrition and Food Technology Research Institute | (+9821)22376471 | neytr@yahoo.com |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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