- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00754390
Effects of Calcium and Phytate on Zinc Absorption
May 24, 2018 updated by: USDA Grand Forks Human Nutrition Research Center
This study is determine the effects of dietary calcium and phytate on zinc absorption.
Study Overview
Status
Completed
Conditions
Detailed Description
Zinc absorption is tested from 2 days of consuming each of four diets with zinc-65 isotope, followed by retention monitoring in a whole body scintillation counter for 4 weeks.
All four 4 experimental diets are tested with each subject, in randomized order, for a total of 16 weeks.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Dakota
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Grand Forks, North Dakota, United States, 58202
- United States Department of Agriculture Grand Forks Human Nutrition Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Average weight for height
Exclusion Criteria:
- Medications other than birth control pills or hormone replacement therapy,
- Pregnancy within last 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Overall Study
Participants consumed 4 experimental diets for 4 weeks each in randomized order
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Participants consumed diet containing 700 milligrams calcium and 440 milligrams of phytate for 4 weeks
Participants consumed diet containing 700 milligrams calcium and 1800 milligrams of phytate for 4 weeks
Participants consumed diet containing 1900 milligrams calcium and 440 milligrams of phytate for 4 weeks
Participants consumed diet containing 1900 milligrams calcium and 1800 milligrams of phytate for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Zinc Absorption
Time Frame: 16 weeks
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Retention of Zinc-65 was monitored for 28 days by whole body scintillation counting.
The percentage of Zinc-65 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Zinc-65 retained versus time
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Janet R Hunt, USDA Grand Forks Human Nutrition Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
September 16, 2008
First Submitted That Met QC Criteria
September 17, 2008
First Posted (Estimate)
September 18, 2008
Study Record Updates
Last Update Posted (Actual)
July 2, 2018
Last Update Submitted That Met QC Criteria
May 24, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GFHNRC042
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.