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

• Sponsor: National Nutrition and Food Technology Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00864539
• Collaborator: (none)
• Enrollment: 585
• Arms: 6
• Duration (Months): 31

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Status; Healthy	Dietary Supplement: fortified milk; Dietary Supplement: plain milk; Dietary Supplement: fortified orange juice; Dietary Supplement: plain orange juice; Dietary Supplement: calcium-vitamin D supplement; Dietary Supplement: Placebo	Phase 2/Phase 3

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

• Study Type: Interventional
• Actual Enrollment: 585 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• 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
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fortified milk daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 mL	Dietary Supplement: fortified milk; daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 ml package for 10 weeks; Other Names: FM
Active Comparator: plain milk daily intake of 200 mL plain milk	Dietary Supplement: plain milk; daily intake of 200 ml plain milk; Other Names: PM
Experimental: fortified orange juice daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium	Dietary Supplement: fortified orange juice; daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium/250 ml package; Other Names: FJ
Active Comparator: plane juice subjects receiving plain orange juice	Dietary Supplement: plain orange juice; daily intake of 250 ml plain orange juice; Other Names: PJ
Experimental: vitamin D-Ca supplement Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D	Dietary Supplement: calcium-vitamin D supplement; daily calcium-vitamin D supplement (500 mg calcium + 200 IU vitamin D); Other Names: SP
Placebo Comparator: Placebo Subjects receiving daily placebo containing 1g starch	Dietary Supplement: Placebo; daily placebo; Other Names: PL

Outcome Measures

Primary Outcome Measures

1. Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group [10 weeks]

   Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Nutrition and Food Technology Institute

Investigators

• Study Chair: Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Research Institute, P.O. Box 19295-4741

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tirang R. Neyestani, associate professor, National Nutrition and Food Technology Institute
• ClinicalTrials.gov Identifier: NCT00864539
• Other Study ID Numbers: P/25/47/2027
• First Posted: Mar 18, 2009
• Last Update Posted: Nov 21, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Tirang R. Neyestani, associate professor, National Nutrition and Food Technology Institute: vitamin D fortification; milk; orange juice; supplement; efficacy
• Additional relevant MeSH terms: Vitamin D; Calcium

Study Results

Participant Flow

Arm/Group Title	Fortified Milk	Plain Milk	Fortified Orange Juice	Plain Juice	Vitamin D-Calcium Supplement	Placebo
Arm/Group Description	daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL	daily intake of 200 mL plain milk	daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium	subjects receiving plain orange juice	Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D	Subjects receiving daily placebo containing 1 g starch
Period Title: Overall Study
STARTED	104	95	102	96	103	85
COMPLETED	95	72	92	89	81	71
NOT COMPLETED	9	23	10	7	22	14

Baseline Characteristics

Arm/Group Title	Fortified Milk	Plain Milk	Fortified Orange Juice	Plain Juice	Vitamin D-Calcium Supplement	Placebo	Total
Arm/Group Description	daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL	daily intake of 200 mL plain milk	daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium	subjects receiving plain orange juice	Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D	Subjects receiving daily placebo containing 1 g starch	Total of all reporting groups
Overall Participants	104	95	102	96	103	85	585
Age (Count of Participants)
<=18 years	104 100%	95 100%	102 100%	96 100%	103 100%	85 100%	585 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.3 (0.7)	10.1 (0.8)	10.1 (0.6)	9.9 (0.8)	10.4 (0.6)	9.8 (0.8)	10.1 (0.8)
Sex: Female, Male (Count of Participants)
Female	51 49%	50 52.6%	48 47.1%	65 67.7%	79 76.7%	59 69.4%	352 60.2%
Male	53 51%	45 47.4%	54 52.9%	31 32.3%	24 23.3%	26 30.6%	233 39.8%
Region of Enrollment (participants) [Number]
Iran, Islamic Republic of	104 100%	95 100%	102 100%	96 100%	103 100%	85 100%	585 100%
Serum levels of 25(OH)D (nmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [nmol/L]	30.5 (24.7)	25.0 (17.2)	18.0 (14.4)	26.6 (22.0)	16.6 (17.8)	19.6 (23.7)	23.0 (20.9)

Outcome Measures

1. Primary Outcome

Title	Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group
Description	Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fortified Milk	Plain Milk	Fortified Orange Juice	Plain Juice	Vitamin D-Calcium Supplement	Placebo
Arm/Group Description	daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL	daily intake of 200 mL plain milk	daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium	subjects receiving plain orange juice	Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D	Subjects receiving daily placebo containing 1 g starch
Measure Participants	104	95	102	96	103	85
Mean (Standard Deviation) [nmol/L]	21.6 (16.6)	21.2 (17.0)	33.3 (27.6)	31.5 (34.0)	26.0 (24.3)	21.8 (28.2)

Adverse Events

Time Frame	3 months
Arm/Group Title	Fortified Milk		Plain Milk		Fortified Orange Juice		Plain Juice		Vitamin D-Calcium Supplement		Placebo
Arm/Group Description	daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL		daily intake of 200 mL plain milk		daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium		subjects receiving plain orange juice		Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D		Subjects receiving daily placebo containing 1 g starch
All Cause Mortality
	Fortified Milk		Plain Milk		Fortified Orange Juice		Plain Juice		Vitamin D-Calcium Supplement		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Fortified Milk		Plain Milk		Fortified Orange Juice		Plain Juice		Vitamin D-Calcium Supplement		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		0/95 (0%)		0/102 (0%)		0/96 (0%)		0/103 (0%)		0/85 (0%)
Other (Not Including Serious) Adverse Events
	Fortified Milk		Plain Milk		Fortified Orange Juice		Plain Juice		Vitamin D-Calcium Supplement		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		0/95 (0%)		0/102 (0%)		0/96 (0%)		0/103 (0%)		0/85 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.