Non-anemic Iron DeficiencyPhase 2/3NCT02683369
Low-dose Iron Supplementation and Markers of Iron Status Among Non-anemic, Iron-deficient Women
A Phase 2/3 study testing Blood Builder®/Iron Response® in people with Non-anemic Iron Deficiency, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Healthy premenopausal women that are iron-deficient without anemia will receive a low-dose iron dietary supplement. The investigators seek to determine if the low-dose iron dietary supplement will restore iron levels to normal range with fewer side effects than typically experienced at higher doses of iron… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Non-anemic Iron Deficiency
- What is being tested?
- Blood Builder®/Iron Response®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to May 2017
- Phase
- Phase 2/3
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pre-menopausal
- Iron deficient without anemia (serum ferritin concentration < 20 ug/L and a hemoglobin concentration > 120 g/L)
- Agree to continue with current diet and any dietary supplements
- Able to understand and write English
- Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
Who cannot join
- Daily supplementation of another iron supplement (other than multivitamin) currently or within past 2 weeks
- Pregnant or breastfeeding females
- History of alcohol, drug, or medication abuse
- Known allergies to any substance in the study product
- Donated blood in the past month or plan to do so at any time during the 8-week trial
- Current diagnosis of inflammatory bowel disease (Crohn's or Ulcerative Colitis)
- Taking medication that my interfere with the absorption of iron
- Current tobacco smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Integrative Medicine University of Maryland
Baltimore, Maryland, 21201
About this study
Official title: Effects of a Commercially-available, Low-dose Iron Supplement (BloodBuilder®/Iron Response®) on Markers of Iron Status Among Premenopausal and Non-anemic, Iron-deficient Women
Healthy premenopausal women that are iron-deficient without anemia will receive a low-dose iron dietary supplement. The investigators seek to determine if the low-dose iron dietary supplement will restore iron levels to normal range with fewer side effects than typically experienced at higher doses of iron supplementation.
Read the detailed description
The primary purpose of this clinical trial is to evaluate the impact of a low-dose iron dietary supplement on markers of iron status among a sample of premenopausal women that are iron-deficient without anemia. This study will also assess the incidence of mild adverse events (constipation, nausea, etc.) that are relatively common with other over the counter iron dietary supplements and that the investigators hypothesize will be reduced with this lower-dose formulation.
- Conditions
- Non-anemic Iron Deficiency
- Being tested
- Blood Builder®/Iron Response®
- Keywords
- Non-anemic Iron Deficiency, Iron Supplementation
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Builder®/Iron Response®Dietary supplement
Also called Low-dose iron dietary supplement
The low-dose iron dietary supplement is a tablet that contains vitamins and minerals selected to help maintain healthy red blood cells and iron levels in the blood. The supplement ingredients aim to generate a supplement by taking a food which contains the naturally occurring, complex matrix of proteins, lipids, carbohydrates and all other elements associated with the vitamin or mineral of interest. These natural food sources are used to generate tablets that maintain the vitamin and mineral potency found in the original food source as well as the associated elements that naturally accompany it.
One tablet will be taken once a day offering a total daily serving of:
- 15 mg of Vitamin C
- 400 mcg of Folate
- 30 mcg Vitamin of B-12
- 26 mg of Iron
- 125 mg of Beet Root
| Study group | Role | What they receive |
|---|---|---|
| Iron Supplement | Experimental | Participants will consume one tablet of Blood Builder®/Iron Response®, once per day, every day, for 8 weeks. Receives: Dietary Supplement: Blood Builder®/Iron Response® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Hemoglobin (Hgb) Level
Marker of iron status
Measured: Baseline and study end (8 weeks from baseline)
Changes in Serum Ferritin (SF) Level
Marker of iron status
Measured: Baseline and study end (8 weeks from baseline)
Changes in Soluble Transferrin Receptor (sTfR) Level
Marker of iron status
Measured: Baseline and study end (8 weeks from baseline)
Changes in Total Body Iron Stores
Marker of iron status
Measured: Baseline and study end (8 weeks from baseline)
Secondary outcomes (8)
Frequency and severity of self-reported constipation
Measured: Study end (8 weeks from baseline)
Frequency and severity of self-reported diarrhea
Measured: Study end (8 weeks from baseline)
Frequency and severity of self-reported nausea
Measured: Study end (8 weeks from baseline)
Frequency and severity of self-reported vomiting
Measured: Study end (8 weeks from baseline)
Frequency and severity of self-reported fatigue
Measured: Baseline and study end (8 weeks from baseline)
Self-reported energy level
Measured: Baseline and study end (8 weeks from baseline)
Supplement compliance assessed using participant daily diary
Measured: Study end (8 weeks from baseline)
Adverse events
Measured: Study end (8 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-anemic Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris D'Adamo, University of Maryland, Baltimore
- Investigators
- Chris D'Adamo, PhD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683369
- Sponsor's protocol ID
- 017-FS; HP-00067251
- Status last verified
- Aug 2019
- First submitted
- 9 Feb 2016
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
D'Adamo CR, Novick JS, Feinberg TM, Dawson VJ, Miller LE. A Food-Derived Dietary Supplement Containing a Low Dose of Iron Improved Markers of Iron Status Among Nonanemic Iron-Deficient Women. J Am Coll Nutr. 2018 May-Jun;37(4):342-349. doi: 10.1080/07315724.2018.1427158. Epub 2018 Mar 13.
PubMed 29533710
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Commercially-available, Low-dose Iron Supplement (BloodBuilder®/Iron Response®) on Markers of Iron Status Among Premenopausal and Non-anemic, Iron-deficient Women
- ClinicalTrials.gov ID
- NCT02683369
- Acronym / sponsor ID
- 017-FS; HP-00067251
- Conditions
- Non-anemic Iron Deficiency
- Keywords
- Non-anemic Iron Deficiency, Iron Supplementation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 17 Feb 2016 (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.
Healthy premenopausal women that are iron-deficient without anemia will receive a low-dose iron dietary supplement. The investigators seek to determine if the low-dose iron dietary supplement will restore iron levels to normal range with fewer side effects than typically experienced at higher doses of iron supplementation.
Detailed description
The primary purpose of this clinical trial is to evaluate the impact of a low-dose iron dietary supplement on markers of iron status among a sample of premenopausal women that are iron-deficient without anemia. This study will also assess the incidence of mild adverse events (constipation, nausea, etc.) that are relatively common with other over the counter iron dietary supplements and that the investigators hypothesize will be reduced with this lower-dose formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron Supplement | Experimental | Dietary Supplement: Blood Builder®/Iron Response®Participants will consume one tablet of Blood Builder®/Iron Response®, once per day, every day, for 8 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pre-menopausal
- Iron deficient without anemia (serum ferritin concentration < 20 ug/L and a hemoglobin concentration > 120 g/L)
- Agree to continue with current diet and any dietary supplements
- Able to understand and write English
- Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
Key exclusion criteria (8 listed)
- Daily supplementation of another iron supplement (other than multivitamin) currently or within past 2 weeks
- Pregnant or breastfeeding females
- History of alcohol, drug, or medication abuse
- Known allergies to any substance in the study product
- Donated blood in the past month or plan to do so at any time during the 8-week trial
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 |
|---|---|---|
| Blood Builder®/Iron Response®Also: Low-dose iron dietary supplementThe low-dose iron dietary supplement is a tablet that contains vitamins and minerals selected to help maintain healthy red blood cells and iron levels in the blood. The supplement ingredients aim to generate a supplement by taking a food which contains the naturally occurring, complex matrix of proteins, lipids, carbohydrates and all other elements associated with the vitamin or mineral of interest. These natural food sources are used to generate tablets that maintain the vitamin and mineral potency found in the original food source as well as the associated elements that naturally accompany it. One tablet will be taken once a day offering a total daily serving of: * 15 mg of Vitamin C * 400 mcg of Folate * 30 mcg Vitamin of B-12 * 26 mg of Iron * 125 mg of Beet Root | Dietary supplement | Iron Supplement |
Primary outcome
Changes in Hemoglobin (Hgb) Level
Time frame: Baseline and study end (8 weeks from baseline)
Marker of iron status
Changes in Serum Ferritin (SF) Level
Time frame: Baseline and study end (8 weeks from baseline)
Marker of iron status
Changes in Soluble Transferrin Receptor (sTfR) Level
Time frame: Baseline and study end (8 weeks from baseline)
Marker of iron status
Changes in Total Body Iron Stores
Time frame: Baseline and study end (8 weeks from baseline)
Marker of iron status
8 secondary outcomes
Frequency and severity of self-reported constipation
Time frame: Study end (8 weeks from baseline)
Frequency and severity of self-reported diarrhea
Time frame: Study end (8 weeks from baseline)
Frequency and severity of self-reported nausea
Time frame: Study end (8 weeks from baseline)
Frequency and severity of self-reported vomiting
Time frame: Study end (8 weeks from baseline)
Frequency and severity of self-reported fatigue
Time frame: Baseline and study end (8 weeks from baseline)
Self-reported energy level
Time frame: Baseline and study end (8 weeks from baseline)
Supplement compliance assessed using participant daily diary
Time frame: Study end (8 weeks from baseline)
Adverse events
Time frame: Study end (8 weeks from baseline)
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 16 Aug 2019.
- Derived from this study: PubMed 29533710D'Adamo CR, Novick JS, Feinberg TM, Dawson VJ, Miller LE. A Food-Derived Dietary Supplement Containing a Low Dose of Iron Improved Markers of Iron Status Among Nonanemic Iron-Deficient Women. J Am Coll Nutr. 2018 May-Jun;37(4):342-349. doi: 10.1080/07315724.2018.1427158. Epub 2018 Mar 13.
- Individual participant dataSharing planned: Undecided
Related trials for Non-anemic Iron Deficiency
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Recruiting
Risk of Anemia and Effects of Oral Iron Therapy in Non-Anemic Iron-Deficient Women (18-55 Years)
Non-Anemic Iron Deficiency
Active, not recruiting
The Immediate and Long-term Effects of a Novel Marine-based Iron Supplement in Adult Females
Anemia, Iron Deficiency (Without Anemia)
RecruitingObservational study
Non-invasive Detection of Iron Deficiency in Obstetrics
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Effect of Chitin and Ascorbic Acid on Dietary Insect Iron Absorption
Iron Deficiency (Without Anemia)
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.
Chris D'Adamo, PhD principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Blood Builder®/Iron Response® in people with Non-anemic Iron Deficiency, run by University of Maryland, Baltimore 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 5 inclusion and 8 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 16 Aug 2019. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in Hemoglobin (Hgb) Level (time frame: Baseline and study end (8 weeks from baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02683369, which also lists 1 linked publication.
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 16 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.