Trial Outcomes & Findings for Comparison of the Efficacy of Calcium-cholecalciferol Foodstuffs and Calcium-cholecalciferol Supplement (NCT NCT00864539)

NCT ID: NCT00864539

Last Updated: 2011-11-21

Results Overview

Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

585 participants

Primary outcome timeframe

10 weeks

Results posted on

2011-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Fortified Milk daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL	Plain Milk daily intake of 200 mL plain milk	Fortified Orange Juice daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium	Plain Juice subjects receiving plain orange juice	Vitamin D-Calcium Supplement Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D	Placebo Subjects receiving daily placebo containing 1 g starch
Overall Study STARTED	104	95	102	96	103	85
Overall Study COMPLETED	95	72	92	89	81	71
Overall Study NOT COMPLETED	9	23	10	7	22	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of the Efficacy of Calcium-cholecalciferol Foodstuffs and Calcium-cholecalciferol Supplement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fortified Milk n=104 Participants daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL	Plain Milk n=95 Participants daily intake of 200 mL plain milk	Fortified Orange Juice n=102 Participants daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium	Plain Juice n=96 Participants subjects receiving plain orange juice	Vitamin D-Calcium Supplement n=103 Participants Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D	Placebo n=85 Participants Subjects receiving daily placebo containing 1 g starch	Total n=585 Participants Total of all reporting groups
Age, Categorical <=18 years	104 Participants n=5 Participants	95 Participants n=7 Participants	102 Participants n=5 Participants	96 Participants n=4 Participants	103 Participants n=21 Participants	85 Participants n=10 Participants	585 Participants n=115 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=10 Participants	0 Participants n=115 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=10 Participants	0 Participants n=115 Participants
Age Continuous	10.3 years STANDARD_DEVIATION 0.7 • n=5 Participants	10.1 years STANDARD_DEVIATION 0.8 • n=7 Participants	10.1 years STANDARD_DEVIATION 0.6 • n=5 Participants	9.9 years STANDARD_DEVIATION 0.8 • n=4 Participants	10.4 years STANDARD_DEVIATION 0.6 • n=21 Participants	9.8 years STANDARD_DEVIATION 0.8 • n=10 Participants	10.1 years STANDARD_DEVIATION 0.8 • n=115 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	50 Participants n=7 Participants	48 Participants n=5 Participants	65 Participants n=4 Participants	79 Participants n=21 Participants	59 Participants n=10 Participants	352 Participants n=115 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	45 Participants n=7 Participants	54 Participants n=5 Participants	31 Participants n=4 Participants	24 Participants n=21 Participants	26 Participants n=10 Participants	233 Participants n=115 Participants
Region of Enrollment Iran, Islamic Republic of	104 participants n=5 Participants	95 participants n=7 Participants	102 participants n=5 Participants	96 participants n=4 Participants	103 participants n=21 Participants	85 participants n=10 Participants	585 participants n=115 Participants
Serum levels of 25(OH)D	30.5 nmol/L STANDARD_DEVIATION 24.7 • n=5 Participants	25.0 nmol/L STANDARD_DEVIATION 17.2 • n=7 Participants	18.0 nmol/L STANDARD_DEVIATION 14.4 • n=5 Participants	26.6 nmol/L STANDARD_DEVIATION 22.0 • n=4 Participants	16.6 nmol/L STANDARD_DEVIATION 17.8 • n=21 Participants	19.6 nmol/L STANDARD_DEVIATION 23.7 • n=10 Participants	23.0 nmol/L STANDARD_DEVIATION 20.9 • n=115 Participants

PRIMARY outcome

Timeframe: 10 weeks

Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.