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Effects of Calcium and Phytate on Zinc Absorption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00754390
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : June 8, 2009
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
USDA Grand Forks Human Nutrition Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (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
Enrollment 17
Recruitment Details 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 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.
Arm/Group Title Calcium and Phytate Interactions
Hide Arm/Group Description 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
Period Title: Ca/Phytate Test Meal 1 (Randomized)
Started 17
Completed 12
Not Completed 5
Reason Not Completed
Withdrawal by Subject             3
Protocol Violation             2
Period Title: Ca/Phytate Test Meal 2 (Randomized)
Started 12
Completed 12
Not Completed 0
Period Title: Ca/Phytate Test Meal 3 (Randomized)
Started 12
Completed 11
Not Completed 1
Reason Not Completed
Protocol Violation             1
Period Title: Ca/Phytate Test Meal 4 (Randomized)
Started 11
Completed 10
Not Completed 1
Reason Not Completed
Protocol Violation             1
Arm/Group Title Entire Study Population
Hide Arm/Group Description 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
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
32.7  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
17
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Zinc Absorption
Hide Description 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
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis restricted to women who completed all 4 treatment periods
Arm/Group Title Moderate Calcium, Low Phytate Diet Moderate Calcium, High Phytate Diet High Calcium, Low Phytate Diet High Calcium, High Phytate Diet
Hide Arm/Group Description:
Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 440 milligrams of phytate per day
Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 1800 milligrams of phytate per day
Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 440 milligrams of phytate per day
Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 1800 milligrams of phytate per day
Overall Number of Participants Analyzed 10 10 10 10
Mean (Standard Error)
Unit of Measure: Percentage of Zinc-65 absorbed
32.8  (2.3) 26.9  (2.4) 39.4  (2.4) 26.2  (2.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate Calcium, Low Phytate Diet, Moderate Calcium, High Phytate Diet, High Calcium, Low Phytate Diet, High Calcium, High Phytate Diet
Comments Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium does not affect zinc absorption
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Moderate Calcium, Low Phytate Diet, Moderate Calcium, High Phytate Diet, High Calcium, Low Phytate Diet, High Calcium, High Phytate Diet
Comments Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary Phytate does not affect zinc absorption
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Moderate Calcium, Low Phytate Diet, Moderate Calcium, High Phytate Diet, High Calcium, Low Phytate Diet, High Calcium, High Phytate Diet
Comments Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium and dietary phytate do not affect zinc absorption. Eight women were required to detect a difference in zinc absorption of 7 percentage points with a power of 90%, alpha level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Study
Hide Arm/Group Description Participants consumed 4 dietary treatments in randomized order
All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Overall Study
Affected / at Risk (%)
Total   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall Study
Affected / at Risk (%)
Total   0/17 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brenda Ling
Organization: United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center
Phone: 701-795-8300
EMail: brenda.ling@ars.usda.gov
Layout table for additonal information
Responsible Party: USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00754390    
Other Study ID Numbers: GFHNRC042
First Submitted: September 16, 2008
First Posted: September 18, 2008
Results First Submitted: December 17, 2008
Results First Posted: June 8, 2009
Last Update Posted: July 2, 2018