FindTrial
Sign In

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

The Prevalence of Vitamin D Insufficiency in Primary School Children and Comparison of the Effect of Calcium-Vitamin D-Fortified Milk, -Orange Juice and Calcium-Vitamin D Supplement

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00864539
Enrollment
585
Registered
2009-03-18
Start date
2007-11-30
Completion date
2010-06-30
Last updated
2011-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Status, Healthy

Keywords

vitamin D fortification, milk, orange juice, supplement, efficacy

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTfortified milk

daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 ml package for 10 weeks

DIETARY_SUPPLEMENTplain milk

daily intake of 200 ml plain milk

DIETARY_SUPPLEMENTfortified orange juice

daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium/250 ml package

DIETARY_SUPPLEMENTplain orange juice

daily intake of 250 ml plain orange juice

DIETARY_SUPPLEMENTcalcium-vitamin D supplement

daily calcium-vitamin D supplement (500 mg calcium + 200 IU vitamin D)

DIETARY_SUPPLEMENTPlacebo

daily placebo

Sponsors

National Nutrition and Food Technology Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
9 Years to 11 Years
Healthy volunteers
Yes

Inclusion criteria

* Age: 9-11 years * Being healthy (no apparent clinical disease) * Informed consent signed by child's parent(s)

Exclusion criteria

* Subjects receiving vitamin D, calcium or omega-3 supplement * Unwillingness to continue the study * Subjects with type 1 diabetes, allergy, kidney disorders

Design outcomes

Primary

MeasureTime frameDescription
Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group10 weeksSerum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.

Participant flow

Participants by arm

ArmCount
Fortified Milk
daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
104
Plain Milk
daily intake of 200 mL plain milk
95
Fortified Orange Juice
daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
102
Plain Juice
subjects receiving plain orange juice
96
Vitamin D-Calcium Supplement
Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
103
Placebo
Subjects receiving daily placebo containing 1 g starch
85
Total585

Baseline characteristics

CharacteristicFortified MilkPlain MilkFortified Orange JuicePlain JuiceVitamin D-Calcium SupplementPlaceboTotal
Age, Categorical
<=18 years
104 Participants95 Participants102 Participants96 Participants103 Participants85 Participants585 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age Continuous10.3 years
STANDARD_DEVIATION 0.7
10.1 years
STANDARD_DEVIATION 0.8
10.1 years
STANDARD_DEVIATION 0.6
9.9 years
STANDARD_DEVIATION 0.8
10.4 years
STANDARD_DEVIATION 0.6
9.8 years
STANDARD_DEVIATION 0.8
10.1 years
STANDARD_DEVIATION 0.8
Region of Enrollment
Iran, Islamic Republic of
104 participants95 participants102 participants96 participants103 participants85 participants585 participants
Serum levels of 25(OH)D30.5 nmol/L
STANDARD_DEVIATION 24.7
25.0 nmol/L
STANDARD_DEVIATION 17.2
18.0 nmol/L
STANDARD_DEVIATION 14.4
26.6 nmol/L
STANDARD_DEVIATION 22
16.6 nmol/L
STANDARD_DEVIATION 17.8
19.6 nmol/L
STANDARD_DEVIATION 23.7
23.0 nmol/L
STANDARD_DEVIATION 20.9
Sex: Female, Male
Female
51 Participants50 Participants48 Participants65 Participants79 Participants59 Participants352 Participants
Sex: Female, Male
Male
53 Participants45 Participants54 Participants31 Participants24 Participants26 Participants233 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
0 / 1040 / 950 / 1020 / 960 / 1030 / 85
serious
Total, serious adverse events
0 / 1040 / 950 / 1020 / 960 / 1030 / 85

Outcome results

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.

Time frame: 10 weeks

ArmMeasureValue (MEAN)Dispersion
Fortified MilkSerum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group21.6 nmol/LStandard Deviation 16.6
Plain MilkSerum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group21.2 nmol/LStandard Deviation 17
Fortified Orange JuiceSerum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group33.3 nmol/LStandard Deviation 27.6
Plain JuiceSerum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group31.5 nmol/LStandard Deviation 34
Vitamin D-Calcium SupplementSerum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group26.0 nmol/LStandard Deviation 24.3
PlaceboSerum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group21.8 nmol/LStandard Deviation 28.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026