Phase 3
Completed N=585
Comparison of the Efficacy of Calcium-cholecalciferol Foodstuffs and Calcium-cholecalciferol Supplement
Vitamin D Status · Healthy
Source: ClinicalTrials.gov NCT00864539 ↗
Enrolled (actual)
585
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcomePrimary: Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group — 21.6; 21.2; 33.3; 31.5 nmol/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group |
21.6; 21.2; 33.3; 31.5; 26.0; 21.8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00864539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.