Effects of Calcium and Phytate on Zinc Absorption

This study has been completed.

Sponsor:

Information provided by:

USDA Grand Forks Human Nutrition Research Center

ClinicalTrials.gov Identifier:

NCT00754390

First received: September 16, 2008

Last updated: May 31, 2011

Last verified: May 2011

History of Changes

Results First Received: December 17, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-availability Study; Intervention Model: Factorial Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Dietary Zinc Absorption
Interventions:	Dietary Supplement: Moderate Calcium, Low phytate Diet Dietary Supplement: Moderate Calcium, High Phytate Diet Dietary Supplement: High Calcium, Low Phytate Diet Dietary Supplement: High Calcium, High Phytate Diet

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Women were recruited by the United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center to participate in an out-patient feeding study in Grand Forks, North Dakota

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
205 participants applied, 157 were eligible, 27 accepted invitation to attend an information meeting, 10 started study, 7 of the alternates joined study as original participants withdrew or were discharged.

Reporting Groups

	Description
Calcium and Phytate Interactions	Subjects consumed 4 test meals (Moderate Calcium (Ca),Low Phytate; Moderate Ca,High Phytate; High Ca,Low Phytate; High Ca,High Phytate) in random order

Participant Flow for 4 periods

Period 1: Ca/Phytate Test Meal 1 (Randomized)

	Calcium and Phytate Interactions
STARTED	17
COMPLETED	12
NOT COMPLETED	5
Withdrawal by Subject	3
Protocol Violation	2

Period 2: Ca/Phytate Test Meal 2 (Randomized)

	Calcium and Phytate Interactions
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Period 3: Ca/Phytate Test Meal 3 (Randomized)

	Calcium and Phytate Interactions
STARTED	12
COMPLETED	11
NOT COMPLETED	1
Protocol Violation	1

Period 4: Ca/Phytate Test Meal 4 (Randomized)

	Calcium and Phytate Interactions
STARTED	11
COMPLETED	10
NOT COMPLETED	1
Protocol Violation	1

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	Includes all subjects randomized to the 4 treatments. Treatments were assigned in randomized order so the number of subjects starting the study does not equal the starting number for a given treatment

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	17
Age [units: participants]
<=18 years	0
Between 18 and 65 years	17
>=65 years	0
Age [units: years] Mean ± Standard Deviation	32.7 ± 9.5
Gender [units: Participants]
Female	17
Male	0

Outcome Measures

1. Primary:

Zinc Absorption [ Time Frame: 16 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Brenda Ling
Organization: United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center
phone: 701-795-8300
e-mail: brenda.ling@ars.usda.gov

No publications provided

Responsible Party:	Janet R Hunt, Research Nutritiontist, United States Department of Agriculture Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:	NCT00754390 History of Changes
Other Study ID Numbers:	GFHNRC042
Study First Received:	September 16, 2008
Results First Received:	December 17, 2008
Last Updated:	May 31, 2011
Health Authority:	United States: Federal Government

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