Vitamin D StatusPhase 2/3NCT00864539
Comparison of the Efficacy of Calcium-cholecalciferol Foodstuffs and Calcium-cholecalciferol Supplement
A Phase 2/3 study testing fortified milk, plain milk and fortified orange juice in people with Vitamin D Status and Healthy, run by National Nutrition and Food Technology Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Status, Healthy
- What is being tested?
- fortified milk, plain milk and fortified orange juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 585 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Jun 2010
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 9-11 years
- Being healthy (no apparent clinical disease)
- Informed consent signed by child's parent(s)
Who cannot join
- Subjects receiving vitamin D, calcium or omega-3 supplement
- Unwillingness to continue the study
- Subjects with type 1 diabetes, allergy, kidney disorders
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Vitamin D Status, Healthy
- Being tested
- fortified milk, plain milk, fortified orange juice, plain orange juice, calcium-vitamin D supplement
- Keywords
- vitamin D fortification, milk, orange juice, supplement, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fortified milkDietary supplement
Also called FM
daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 ml package for 10 weeks
plain milkDietary supplement
Also called PM
daily intake of 200 ml plain milk
fortified orange juiceDietary supplement
Also called FJ
daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium/250 ml package
plain orange juiceDietary supplement
Also called PJ
daily intake of 250 ml plain orange juice
calcium-vitamin D supplementDietary supplement
Also called SP
daily calcium-vitamin D supplement (500 mg calcium + 200 IU vitamin D)
PlaceboDietary supplement
Also called PL
daily placebo
| Study group | Role | What they receive |
|---|---|---|
| fortified milk | Experimental | daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 mL Receives: Dietary Supplement: fortified milk |
| plain milk | Active comparator | daily intake of 200 mL plain milk Receives: Dietary Supplement: plain milk |
| fortified orange juice | Experimental | daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium Receives: Dietary Supplement: fortified orange juice |
| plane juice | Active comparator | subjects receiving plain orange juice Receives: Dietary Supplement: plain orange juice |
| vitamin D-Ca supplement | Experimental | Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D Receives: Dietary Supplement: calcium-vitamin D supplement |
| Placebo | Placebo comparator | Subjects receiving daily placebo containing 1g starch Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startNov 2007
- Primary completionFeb 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vitamin D StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tirang R. Neyestani, National Nutrition and Food Technology Institute
- Investigators
- Tirang R. Neyestani, Ph.D., Study chair, National Nutrition and Food Technology Research Institute, P.O. Box 19295-4741
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864539
- Sponsor's protocol ID
- P/25/47/2027
- Status last verified
- Nov 2011
- First submitted
- 17 Mar 2009
- Last updated
- 21 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00864539
- Acronym / sponsor ID
- P/25/47/2027
- Conditions
- Vitamin D Status, Healthy
- Keywords
- vitamin D fortification, milk, orange juice, supplement, efficacy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Posted 28 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| fortified milk | Experimental | Dietary Supplement: fortified milkdaily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 mL |
| plain milk | Active comparator | Dietary Supplement: plain milkdaily intake of 200 mL plain milk |
| fortified orange juice | Experimental | Dietary Supplement: fortified orange juicedaily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium |
| plane juice | Active comparator | Dietary Supplement: plain orange juicesubjects receiving plain orange juice |
| vitamin D-Ca supplement | Experimental | Dietary Supplement: calcium-vitamin D supplementSubjects receiving daily supplement containing 500 mg + 200 IU vitamin D |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects receiving daily placebo containing 1g starch |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 9-11 years
- Being healthy (no apparent clinical disease)
- Informed consent signed by child's parent(s)
Key exclusion criteria (3 listed)
- Subjects receiving vitamin D, calcium or omega-3 supplement
- Unwillingness to continue the study
- Subjects with type 1 diabetes, allergy, kidney disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fortified milkAlso: FMdaily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 ml package for 10 weeks | Dietary supplement | fortified milk |
| plain milkAlso: PMdaily intake of 200 ml plain milk | Dietary supplement | plain milk |
| fortified orange juiceAlso: FJdaily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium/250 ml package | Dietary supplement | fortified orange juice |
| plain orange juiceAlso: PJdaily intake of 250 ml plain orange juice | Dietary supplement | plane juice |
| calcium-vitamin D supplementAlso: SPdaily calcium-vitamin D supplement (500 mg calcium + 200 IU vitamin D) | Dietary supplement | vitamin D-Ca supplement |
| PlaceboAlso: PLdaily placebo | Dietary supplement | Placebo |
Primary outcome
Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group
Time frame: 10 weeks
Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tirang R. Neyestani, Ph.D. study chair
National Nutrition and Food Technology Research Institute, P.O. Box 19295-4741
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing fortified milk, plain milk and fortified orange juice in people with Vitamin D Status and Healthy, run by National Nutrition and Food Technology Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2011.