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Effects of Calcium and Phytate on Zinc Absorption

Effects of Calcium and Phytate on Zinc Absorption

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00754390
Enrollment
17
Registered
2008-09-18
Start date
2005-11-30
Completion date
2006-05-31
Last updated
2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Zinc Absorption

Keywords

dietary zinc absorption, dietary phytic acid, dietary calcium

Brief summary

This study is determine the effects of dietary calcium and phytate on zinc absorption.

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.

Interventions

DIETARY_SUPPLEMENTModerate Calcium, Low phytate Diet

Participants consumed diet containing 700 milligrams calcium and 440 milligrams of phytate for 4 weeks

DIETARY_SUPPLEMENTModerate Calcium, High Phytate Diet

Participants consumed diet containing 700 milligrams calcium and 1800 milligrams of phytate for 4 weeks

DIETARY_SUPPLEMENTHigh Calcium, Low Phytate Diet

Participants consumed diet containing 1900 milligrams calcium and 440 milligrams of phytate for 4 weeks

DIETARY_SUPPLEMENTHigh Calcium, High Phytate Diet

Participants consumed diet containing 1900 milligrams calcium and 1800 milligrams of phytate for 4 weeks

Sponsors

USDA Grand Forks Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Average weight for height

Exclusion criteria

* Medications other than birth control pills or hormone replacement therapy, * Pregnancy within last 6 months

Design outcomes

Primary

MeasureTime frameDescription
Zinc Absorption16 weeksRetention 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

Countries

United States

Participant flow

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.

Participants by arm

ArmCount
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
17
Total17

Withdrawals & dropouts

PeriodReasonFG000
Ca/Phytate Test Meal 1 (Randomized)Protocol Violation2
Ca/Phytate Test Meal 1 (Randomized)Withdrawal by Subject3
Ca/Phytate Test Meal 3 (Randomized)Protocol Violation1
Ca/Phytate Test Meal 4 (Randomized)Protocol Violation1

Baseline characteristics

CharacteristicEntire Study Population
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
17 Participants
Age, Continuous32.7 years
STANDARD_DEVIATION 9.5
Sex: Female, Male
Female
17 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 17
serious
Total, serious adverse events
0 / 17

Outcome results

Primary

Zinc Absorption

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

Population: Analysis restricted to women who completed all 4 treatment periods

ArmMeasureValue (MEAN)Dispersion
Moderate Calcium, Low Phytate DietZinc Absorption32.8 Percentage of Zinc-65 absorbedStandard Error 2.3
Moderate Calcium, High Phytate DietZinc Absorption26.9 Percentage of Zinc-65 absorbedStandard Error 2.4
High Calcium, Low Phytate DietZinc Absorption39.4 Percentage of Zinc-65 absorbedStandard Error 2.4
High Calcium, High Phytate DietZinc Absorption26.2 Percentage of Zinc-65 absorbedStandard Error 2.3
Comparison: 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 absorptionp-value: 0.17Mixed Models Analysis
Comparison: 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 absorptionp-value: 0.0002Mixed Models Analysis
Comparison: 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.p-value: 0.09Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026