Dietary Zinc AbsorptionNCT00754390
Effects of Calcium and Phytate on Zinc Absorption
A study testing Moderate Calcium, Low phytate Diet, Moderate Calcium, High Phytate Diet and High Calcium, Low Phytate Diet in people with Dietary Zinc Absorption, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
This study is determine the effects of dietary calcium and phytate on zinc absorption. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Zinc Absorption
- What is being tested?
- Moderate Calcium, Low phytate Diet, Moderate Calcium, High Phytate Diet and High Calcium, Low Phytate Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to May 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Average weight for height
Who cannot join
- Medications other than birth control pills or hormone replacement therapy,
- Pregnancy within last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
United States Department of Agriculture Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58202
About this study
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.
- Conditions
- Dietary Zinc Absorption
- Being tested
- Moderate Calcium, Low phytate Diet, Moderate Calcium, High Phytate Diet, High Calcium, Low Phytate Diet, High Calcium, High Phytate Diet
- Keywords
- dietary zinc absorption, dietary phytic acid, dietary calcium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Calcium, Low phytate DietDietary supplement
Participants consumed diet containing 700 milligrams calcium and 440 milligrams of phytate for 4 weeks
Moderate Calcium, High Phytate DietDietary supplement
Participants consumed diet containing 700 milligrams calcium and 1800 milligrams of phytate for 4 weeks
High Calcium, Low Phytate DietDietary supplement
Participants consumed diet containing 1900 milligrams calcium and 440 milligrams of phytate for 4 weeks
High Calcium, High Phytate DietDietary supplement
Participants consumed diet containing 1900 milligrams calcium and 1800 milligrams of phytate for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Overall Study | Experimental | Participants consumed 4 experimental diets for 4 weeks each in randomized order Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startNov 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dietary Zinc AbsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Janet R Hunt, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754390
- Sponsor's protocol ID
- GFHNRC042
- Status last verified
- May 2018
- First submitted
- 16 Sep 2008
- Last updated
- 2 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Calcium and Phytate on Zinc Absorption
- ClinicalTrials.gov ID
- NCT00754390
- Acronym / sponsor ID
- GFHNRC042
- Conditions
- Dietary Zinc Absorption
- Keywords
- dietary zinc absorption, dietary phytic acid, dietary calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Nov 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Posted 8 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall Study | Experimental | 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 DietParticipants consumed 4 experimental diets for 4 weeks each in randomized order |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Average weight for height
Key exclusion criteria (2 listed)
- Medications other than birth control pills or hormone replacement therapy,
- Pregnancy within last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate Calcium, Low phytate DietParticipants consumed diet containing 700 milligrams calcium and 440 milligrams of phytate for 4 weeks | Dietary supplement | Overall Study |
| Moderate Calcium, High Phytate DietParticipants consumed diet containing 700 milligrams calcium and 1800 milligrams of phytate for 4 weeks | Dietary supplement | Overall Study |
| High Calcium, Low Phytate DietParticipants consumed diet containing 1900 milligrams calcium and 440 milligrams of phytate for 4 weeks | Dietary supplement | Overall Study |
| High Calcium, High Phytate DietParticipants consumed diet containing 1900 milligrams calcium and 1800 milligrams of phytate for 4 weeks | Dietary supplement | Overall Study |
Primary outcome
Zinc Absorption
Time frame: 16 weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dietary Zinc Absorption
Recruiting
Zinc and Iron Absorption From Common Beans in Young Adult Women
Zinc Absorption, Iron Absorption
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet R Hunt principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Calcium, Low phytate Diet, Moderate Calcium, High Phytate Diet and High Calcium, Low Phytate Diet in people with Dietary Zinc Absorption, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zinc Absorption (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.