Iron OverloadNCT01047098
Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation
A study testing Iron in people with Iron Overload and Oxidative Stress, run by University of California, Davis at 1 site in United States.
Trial summary
Most breastfeeding women are told by their health care provider to continue taking prenatal vitamins after they give birth. A woman's requirement for iron while breastfeeding is low, yet prenatal vitamins contain a large amount of iron. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Overload, Oxidative Stress, Iron-deficiency Anemia
- What is being tested?
- Iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women less than 4 weeks postpartum
- 18 years of age or older
- Took prenatal vitamins for at least 3 months during pregnancy
- Successfully initiated breastfeeding
Who cannot join
- Anemic (Hgb < 110 g/L)
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Most breastfeeding women are told by their health care provider to continue taking prenatal vitamins after they give birth. A woman's requirement for iron while breastfeeding is low, yet prenatal vitamins contain a large amount of iron. The purpose of this study is to see if breastfeeding women are getting too much iron when taking prenatal vitamins.
Read the detailed description
Even though iron requirements are much lower for lactating women than for pregnant or non-pregnant, non-lactating women, and iron stores during lactation are often high due to release of iron from the additional maternal erythrocytes produced during pregnancy, iron supplements are often taken by lactating women in the U.S. Many studies have shown that higher iron status is associated with higher risk of certain chronic diseases (e.g. cancer and cardiovascular diseases). The overall goal of this proposed study is to understand the potential for oxidative stress due to iron supplementation, and possible mechanisms for these effects, and to identify safe and efficacious ways to ensure adequate iron status during lactation. The specific aims are:
- To compare markers of lipid oxidation (urinary isoprostane) and DNA damage (urinary 8-OHdG (urinary 8-hydroxy-2'-deoxyguanosine)) among 3 treatment groups: (iron given between meals (27 mg daily, in a multivitamin-mineral supplement), iron given with meals (27 mg daily, in a multivitamin-mineral supplement) and multivitamin-mineral supplement with no iron, given between meals) at the beginning and end of 3 months of treatment in 114 lactating women.
- To compare hemoglobin and iron status (ferritin, transferrin saturation, and hepcidin) before and after treatment among the three treatment groups described above.
- Conditions
- Iron Overload, Oxidative Stress, Iron-deficiency Anemia
- Being tested
- Iron, Placebo
- Keywords
- Lactation, Breastfeeding, Iron, Oxidative stress, Iron status and oxidative stress during lactation
- Medical subject headings
- Iron Overload, Anemia, Iron-Deficiency, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IronDietary supplement
Iron as iron sulfate
IronDietary supplement
Iron as iron sulfate
PlaceboDietary supplement
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Iron with meals | Experimental | Prenatal vitamin without iron plus capsule containing 27 mg of iron taken with meals Receives: Dietary Supplement: Iron |
| Iron between meals | Experimental | Prenatal vitamin without iron plus capsule containing 27 mg of iron taken between meals Receives: Dietary Supplement: Iron |
| Placebo | Placebo comparator | Prenatal vitamin without iron plus capsule containing calcium carbonate (placebo) taken between meals Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress
Isoprostane and 8-OHdG
Measured: 3 month
Iron status
Ferritin, transferrin saturation, hepcidin
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startOct 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron OverloadStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn G Dewey, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047098
- Sponsor's protocol ID
- 200816261
- Status last verified
- May 2017
- First submitted
- 8 Jan 2010
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation
- ClinicalTrials.gov ID
- NCT01047098
- Acronym / sponsor ID
- 200816261
- Conditions
- Iron Overload, Oxidative Stress, Iron-deficiency Anemia
- Keywords
- Lactation, Breastfeeding, Iron, Oxidative stress, Iron status and oxidative stress during lactation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most breastfeeding women are told by their health care provider to continue taking prenatal vitamins after they give birth. A woman's requirement for iron while breastfeeding is low, yet prenatal vitamins contain a large amount of iron. The purpose of this study is to see if breastfeeding women are getting too much iron when taking prenatal vitamins.
Detailed description
Even though iron requirements are much lower for lactating women than for pregnant or non-pregnant, non-lactating women, and iron stores during lactation are often high due to release of iron from the additional maternal erythrocytes produced during pregnancy, iron supplements are often taken by lactating women in the U.S. Many studies have shown that higher iron status is associated with higher risk of certain chronic diseases (e.g. cancer and cardiovascular diseases). The overall goal of this proposed study is to understand the potential for oxidative stress due to iron supplementation, and possible mechanisms for these effects, and to identify safe and efficacious ways to ensure adequate iron status during lactation. The specific aims are:
- To compare markers of lipid oxidation (urinary isoprostane) and DNA damage (urinary 8-OHdG (urinary 8-hydroxy-2'-deoxyguanosine)) among 3 treatment groups: (iron given between meals (27 mg daily, in a multivitamin-mineral supplement), iron given with meals (27 mg daily, in a multivitamin-mineral supplement) and multivitamin-mineral supplement with no iron, given between meals) at the beginning and end of 3 months of treatment in 114 lactating women.
- To compare hemoglobin and iron status (ferritin, transferrin saturation, and hepcidin) before and after treatment among the three treatment groups described above.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iron with meals | Experimental | Dietary Supplement: IronPrenatal vitamin without iron plus capsule containing 27 mg of iron taken with meals |
| Iron between meals | Experimental | Dietary Supplement: IronPrenatal vitamin without iron plus capsule containing 27 mg of iron taken between meals |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPrenatal vitamin without iron plus capsule containing calcium carbonate (placebo) taken between meals |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women less than 4 weeks postpartum
- 18 years of age or older
- Took prenatal vitamins for at least 3 months during pregnancy
- Successfully initiated breastfeeding
Key exclusion criteria (1 listed)
- Anemic (Hgb < 110 g/L)
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 |
|---|---|---|
| IronIron as iron sulfate | Dietary supplement | Iron with meals |
| IronIron as iron sulfate | Dietary supplement | Iron between meals |
| PlaceboPlacebo capsule | Dietary supplement | Placebo |
Primary outcome
Oxidative stress
Time frame: 3 month
Isoprostane and 8-OHdG
Iron status
Time frame: 3 month
Ferritin, transferrin saturation, hepcidin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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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.
Kathryn G Dewey, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron in people with Iron Overload and Oxidative Stress, run by University of California, Davis 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 4 inclusion and 1 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 30 May 2017. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oxidative stress (time frame: 3 month). The study lists 2 primary outcomes in all. 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 30 May 2017.