NCT00864539

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
585

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
4 months until next milestone

Results Posted

Study results publicly available

September 28, 2010

Completed
Last Updated

November 21, 2011

Status Verified

November 1, 2011

Enrollment Period

1.3 years

First QC Date

March 17, 2009

Results QC Date

July 27, 2010

Last Update Submit

November 12, 2011

Conditions

Vitamin D StatusHealthy

Keywords

vitamin D fortificationmilkorange juicesupplementefficacy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

fortified milk

EXPERIMENTAL

daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 mL

Dietary Supplement: fortified milk

plain milk

ACTIVE COMPARATOR

daily intake of 200 mL plain milk

Dietary Supplement: plain milk

fortified orange juice

EXPERIMENTAL

daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium

Dietary Supplement: fortified orange juice

plane juice

ACTIVE COMPARATOR

subjects receiving plain orange juice

Dietary Supplement: plain orange juice

vitamin D-Ca supplement

EXPERIMENTAL

Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D

Dietary Supplement: calcium-vitamin D supplement

Placebo

PLACEBO COMPARATOR

Subjects receiving daily placebo containing 1g starch

Dietary Supplement: Placebo

Interventions

fortified milkDIETARY_SUPPLEMENT

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

Also known as: FM
fortified milk
plain milkDIETARY_SUPPLEMENT

daily intake of 200 ml plain milk

Also known as: PM
plain milk
fortified orange juiceDIETARY_SUPPLEMENT

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

Also known as: FJ
fortified orange juice
plain orange juiceDIETARY_SUPPLEMENT

daily intake of 250 ml plain orange juice

Also known as: PJ
plane juice
calcium-vitamin D supplementDIETARY_SUPPLEMENT

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

Also known as: SP
vitamin D-Ca supplement
PlaceboDIETARY_SUPPLEMENT

daily placebo

Also known as: PL
Placebo

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Tirang R. Neyestani
Organization
National Nutrition and Food Technology Research Institute
neytr@yahoo.com
(+9821)22376471

Study Officials

  • Tirang R. Neyestani, Ph.D.

    National Nutrition and Food Technology Research Institute, P.O. Box 19295-4741

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Study Start

November 1, 2007

Primary Completion

February 1, 2009

Study Completion

June 1, 2010

Last Updated

November 21, 2011

Results First Posted

September 28, 2010

Record last verified: 2011-11