CClinicalTrials.gg
CompletedNCT00754390Updated Jul 2, 2018Results posted

Effects of Calcium and Phytate on Zinc Absorption

An interventional study of Moderate Calcium, Low phytate Diet and Moderate Calcium, High Phytate Diet in Dietary Zinc Absorption, sponsored by USDA Grand Forks Human Nutrition Research Center. Completed at 1 site in United States. Open to female participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-02.

Sponsored by USDA Grand Forks Human Nutrition Research Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dietary Zinc Absorption

Keywords

  • dietary zinc absorption
  • dietary phytic acid
  • dietary calcium
03

In context

Lead sponsor

USDA Grand Forks Human Nutrition Research Center is the lead sponsor of 58 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Average weight for height

Exclusion criteria

Exclusion Criteria:

  • Medications other than birth control pills or hormone replacement therapy,
  • Pregnancy within last 6 months
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Overall Study

    Participants consumed 4 experimental diets for 4 weeks each in randomized order

    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

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

06

What researchers measure

Primary outcomes

  1. 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

07

Results

Posted Jun 8, 2009

Participant flow

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

Ca/Phytate Test Meal 1 (Randomized)
Participant flow — Ca/Phytate Test Meal 1 (Randomized)
MilestoneCalcium and Phytate Interactions
Started17
Completed12
Not completed5
Withdrew: Withdrawal by subject3
Withdrew: Protocol violation2
Ca/Phytate Test Meal 2 (Randomized)
Participant flow — Ca/Phytate Test Meal 2 (Randomized)
MilestoneCalcium and Phytate Interactions
Started12
Completed12
Not completed0
Ca/Phytate Test Meal 3 (Randomized)
Participant flow — Ca/Phytate Test Meal 3 (Randomized)
MilestoneCalcium and Phytate Interactions
Started12
Completed11
Not completed1
Withdrew: Protocol violation1
Ca/Phytate Test Meal 4 (Randomized)
Participant flow — Ca/Phytate Test Meal 4 (Randomized)
MilestoneCalcium and Phytate Interactions
Started11
Completed10
Not completed1
Withdrew: Protocol violation1

Outcome measures

PrimaryZinc 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
Reported as:
Mean · Percentage of Zinc-65 absorbed
Zinc Absorption
Percentage of Zinc-65 absorbedModerate Calcium, Low Phytate DietModerate Calcium, High Phytate DietHigh Calcium, Low Phytate DietHigh Calcium, High Phytate Diet
Zinc Absorption32.8 ± 2.326.9 ± 2.439.4 ± 2.426.2 ± 2.3
Statistical analysis
  • Moderate Calcium, Low Phytate Diet vs Moderate Calcium, High Phytate Diet vs High Calcium, Low Phytate Diet vs High Calcium, High Phytate Diet · Mixed Models Analysis · p = 0.17
  • Moderate Calcium, Low Phytate Diet vs Moderate Calcium, High Phytate Diet vs High Calcium, Low Phytate Diet vs High Calcium, High Phytate Diet · Mixed Models Analysis · p = 0.0002
  • Moderate Calcium, Low Phytate Diet vs Moderate Calcium, High Phytate Diet vs High Calcium, Low Phytate Diet vs High Calcium, High Phytate Diet · Mixed Models Analysis · p = 0.09

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Overall Study—0/17 (0%)0/17 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Entire Study Population
<=18 years0
Between 18 and 65 years17
>=65 years0
Age, Continuous
Age, Continuous(years)Entire Study Population
Mean32.7 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)Entire Study Population
Female17
Male0
08

Study locations

1 site
  • United States Department of Agriculture Grand Forks Human Nutrition Research Center
    Grand Forks, North Dakota 58202, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00754390
Lead sponsor
USDA Grand Forks Human Nutrition Research Center
Responsible party
Sponsor
First posted
Sep 18, 2008
Start date
Nov 2005
Primary completion
May 2006
Completion
May 2006
Results posted
Jun 8, 2009
Last update
Jul 2, 2018

Study contacts

Janet R Hunt
principal investigator · USDA Grand Forks Human Nutrition Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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