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

National Nutrition and Food Technology Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Healthy; Vitamin D Status

Treatments: Dietary Supplement: Placebo; Dietary Supplement: fortified orange juice; Dietary Supplement: calcium-vitamin D supplement; Dietary Supplement: fortified milk; Dietary Supplement: plain orange juice; Dietary Supplement: plain milk

Study type: Interventional

Funder types: Other

Identifiers

NCT00864539

P/25/47/2027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 585 patients

Sex: All

Ages: 9 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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585 participants in 6 patient groups, including a placebo group

fortified milk

Experimental group

Description:

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

Treatment:

Dietary Supplement: fortified milk

plain milk

Active Comparator group

Description:

daily intake of 200 mL plain milk

Treatment:

Dietary Supplement: plain milk

fortified orange juice

Experimental group

Description:

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

Treatment:

Dietary Supplement: fortified orange juice

plane juice

Active Comparator group

Description:

subjects receiving plain orange juice

Treatment:

Dietary Supplement: plain orange juice

vitamin D-Ca supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: calcium-vitamin D supplement

Placebo

Placebo Comparator group

Description:

Subjects receiving daily placebo containing 1g starch

Treatment:

Dietary Supplement: Placebo