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Trial Outcomes & Findings for Effects of Calcium and Phytate on Zinc Absorption (NCT NCT00754390)

NCT ID: NCT00754390

Last Updated: 2018-07-02

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

16 weeks

Results posted on

2018-07-02

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

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.

Participant milestones

Participant milestones
Measure
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
Ca/Phytate Test Meal 1 (Randomized)
STARTED
17
Ca/Phytate Test Meal 1 (Randomized)
COMPLETED
12
Ca/Phytate Test Meal 1 (Randomized)
NOT COMPLETED
5
Ca/Phytate Test Meal 2 (Randomized)
STARTED
12
Ca/Phytate Test Meal 2 (Randomized)
COMPLETED
12
Ca/Phytate Test Meal 2 (Randomized)
NOT COMPLETED
0
Ca/Phytate Test Meal 3 (Randomized)
STARTED
12
Ca/Phytate Test Meal 3 (Randomized)
COMPLETED
11
Ca/Phytate Test Meal 3 (Randomized)
NOT COMPLETED
1
Ca/Phytate Test Meal 4 (Randomized)
STARTED
11
Ca/Phytate Test Meal 4 (Randomized)
COMPLETED
10
Ca/Phytate Test Meal 4 (Randomized)
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
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
Ca/Phytate Test Meal 1 (Randomized)
Withdrawal by Subject
3
Ca/Phytate Test Meal 1 (Randomized)
Protocol Violation
2
Ca/Phytate Test Meal 3 (Randomized)
Protocol Violation
1
Ca/Phytate Test Meal 4 (Randomized)
Protocol Violation
1

Baseline Characteristics

Effects of Calcium and Phytate on Zinc Absorption

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Entire Study Population
n=17 Participants
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
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
17 Participants
n=93 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
Age, Continuous
32.7 years
STANDARD_DEVIATION 9.5 • n=93 Participants
Sex: Female, Male
Female
17 Participants
n=93 Participants
Sex: Female, Male
Male
0 Participants
n=93 Participants

PRIMARY outcome

Timeframe: 16 weeks

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

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

Outcome measures

Outcome measures
Measure
Moderate Calcium, Low Phytate Diet
n=10 Participants
Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 440 milligrams of phytate per day
Moderate Calcium, High Phytate Diet
n=10 Participants
Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 1800 milligrams of phytate per day
High Calcium, Low Phytate Diet
n=10 Participants
Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 440 milligrams of phytate per day
High Calcium, High Phytate Diet
n=10 Participants
Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 1800 milligrams of phytate per day
Zinc Absorption
32.8 Percentage of Zinc-65 absorbed
Standard Error 2.3
26.9 Percentage of Zinc-65 absorbed
Standard Error 2.4
39.4 Percentage of Zinc-65 absorbed
Standard Error 2.4
26.2 Percentage of Zinc-65 absorbed
Standard Error 2.3

Adverse Events

Overall Study

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brenda Ling

United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center

Phone: 701-795-8300

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place