Iron-deficiencyNCT03523455
Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training
A study testing Iron Aid IPS (Iron Protein Succinylate) and Sugar Pill in people with Iron-deficiency, run by University of Mary Hardin-Baylor at 1 site in United States.
Trial summary
Participants are required to undergo a screening and qualification before beginning the study. Once qualified, baseline testing is completed in the laboratory. This testing includes: body composition measurements, a blood draw, questionnaires, a VO2 max test, and a time to exhaustion trial. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- Iron Aid IPS (Iron Protein Succinylate) and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2016to 11 Nov 2017
- 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 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- I am willing to and provide written and dated informed consent form to participate in the study;
- I am female 18-30 years of age;
- I am willing and able to comply with protocol;
- My VO2 max is in compliance with age range (42 ml/kg/min);
- I have not used or consumed any prescription drugs or supplements that could potentially confound the results of the current supplement;
- I am apparently healthy and free from disease, as determined by a health history questionnaire;
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- I agree to abstain from strenuous activity and pre-workout supplementation 48 hours prior to each testing visit;
- I must be fasted for 8 hours prior to each testing visit;
- I agree to abstain from caffeine and alcohol consumption 24 hours prior to each testing visit;
- I do not have any existing muscular disorders;
- I am able to complete all testing on the 8th or 9th day after my menstrual cycle has ended.
Who cannot join
- I use tobacco products or have quit within the past 6 months;
- I am currently pregnant, plan on becoming pregnant, or become pregnant during the duration of the study;
- I have given birth or been pregnant the past year;
- I am currently taking or have taken any oral contraception within the past 6 months;
- I have difficulty giving blood;
- I am currently diagnosed with having or currently involved in a managed treatment plan for any known metabolic disorder including heart disease, arrhythmias, diabetes, gall bladder, thyroid disease, or hypogonadism;
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- I am diagnosed with having or are currently involved in a managed treatment plan for pulmonary disease, hypertension (defined as systolic blood pressure consistently greater than 140 mm Hg and/or a diastolic blood pressure greater than 90 mm Hg), hepatorenal disease, musculoskeletal disorders, neuromuscular/neurological diseases, autoimmune diseases, cancer, peptic ulcers, or anemia;
- I am medically prescribed by a physician to take or regularly take over the counter medications for any heart, pulmonary, thyroid, anti-hyperlipidemic, hypoglycemic, anti-hypertensive, endocrinologic (e.g. thyroid, insulin, etc.), neuromuscular/neurological, or androgenic medications due to possible further health hazards that could occur with diet alteration or exercise training;
- I report any unusual adverse events associated with this study that in consultation with the study investigators or supervision physician recommends removal from the study;
- I have taken ergogenic levels of nutritional supplements that may affect muscle mass or aerobic capacity (e.g., creatine, HMB) or anabolic/catabolic hormone levels (e.g., androstenedione, DHEA, etc.) within 6 months prior to the start of the study;
- I have consumed any iron or mineral type dietary supplements (excluding multivitamins) 1 month prior to the study;
- I have a history of food or drug allergy of any kind;
- I have any other condition in which principal investigator thinks may jeopardize the study or the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training
Participants are required to undergo a screening and qualification before beginning the study. Once qualified, baseline testing is completed in the laboratory. This testing includes: body composition measurements, a blood draw, questionnaires, a VO2 max test, and a time to exhaustion trial. This testing is repeated during week 4 and week 12. At week 8, subjects complete a blood draw and questionnaires only. During the 12 week period, participants will follow an endurance exercise program in which they will train 4 days per week. This is a double-blind study in which participants are randomized into either the placebo or supplement group. They are instructed to ingest the supplement once a day at breakfast. Diet logs are also monitored throughout the duration of the study with the restriction of no red meat.
Read the detailed description
Subjects expressing interest in participating in this study, were interviewed in person to determine whether they appeared to qualify to participate in the study. If they met eligibility criteria, they were invited to attend an entry/familiarization session. During this session, they completed personal and medical histories which were reviewed to determine whether they met eligibility criteria. Once meeting entry criteria, they were familiarized to the study protocol via a verbal and written explanation outlining the study design. Subjects then read and signed the Informed Consent Statements after the study details were explained. Subjects then perform the exercise protocol in which they must have completed in order to qualify for the study.
Subjects were asked to perform a VO2 Max test using the Bruce protocol. Following the VO2 Max test, subjects were given a rest period of 20 minutes before starting the Time to Exhaustion (TTE) trial run. This session familiarized subjects with the exercise protocol preparing them for the qualification testing session. Subjects then returned to the lab in a 12 hour fasted state and completed a VO2max test. If a 42 ml/kg/min or above was achieved subjects were then allowed to complete the 20 minute TTE test. After completion of the TTE, a blood draw was done to access the subject's iron levels. Once results for iron levels returned at a 90 or below subjects were given an appointment time to perform baseline assessments and testing sessions.
Baseline testing (Week 0), Week 8 and Week 12 took place on the 8th or 9th day after the subject's menstrual cycle. Subjects returned to the lab in a 12 hour fasted state, with no strenuous workouts done 48 hours prior to testing. Subjects had their height and weight measured, filled out questionnaires, completed a DEXA scan and InBody to establish current body composition, afterwards having their heart rate and blood pressure assessed. At this point subjects were instructed to lay on a table for their blood draw. Once the blood draw was done, subjects completed a VO2 Max test using the Bruce protocol. Following the VO2 Max testing, subjects filled out 2 questionnaires and were given a rest period of 20 minutes before starting the Time to Exhaustion (TTE) trial run. During the rest period subjects were given a snack to ingest (banana or apple) and consumed the same snack at each testing session. Approximately 12 minutes prior to the TTE subjects filled out a questionnaire. During the TTE run subjects were able to control and see the speed at which they ran but were blinded to the time passed along with the distance completed. After the 20 minutes, the treadmill stopped, distance, heart rate and blood pressure were measured. Afterwards, subjects filled out post exercise questionnaires. At week 0, after all exercise testing was completed, subjects were assigned to a group (either placebo or active) and instructed to ingest 1 capsule per day. A workout log was also provided to each subject, who would return to the lab every Friday with their workout log to access exercise compliance.
At week 4, subjects returned to the lab on the 8th or 9th day after their menstrual cycle to have a blood draw completed to access blood marker variables in addition to questionnaires.
Diet logs were keep throughout the duration of the study and were monitored by lab staff.
- Conditions
- Iron-deficiency
- Being tested
- Iron Aid IPS (Iron Protein Succinylate), Sugar Pill
- Keywords
- Iron, Exercise Performance, Fatigue
- Medical subject headings
- Anemia, Iron-Deficiency, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Aid IPS (Iron Protein Succinylate)Dietary supplement
Taken orally in capsule form
Sugar PillOther
Taken orally in capsule form
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Maltodextrin (matches the weight of the active treatment) Taken once each day after breakfast, but before lunch. Receives: Other: Sugar Pill |
| Iron Aid IPS (Iron Protein Succinylate) | Active comparator | IronAid Iron Protein Succinylate 30 mg Taken once each day after breakfast, but before lunch. Receives: Dietary Supplement: Iron Aid IPS (Iron Protein Succinylate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of IronAid IPS on Iron mcg/dL
The primary purpose is to observe the effect of supplementation on fasting total iron levels prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Ferritin ng/mL
The primary purpose is to observe the effect of supplementation on ferritin levels prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on the Exercise Induced Feeling Inventory
The primary purpose is to observe the effect of supplementation on feelings of fatigue prior to and after exercise testing in the laboratory at Week 0, 4, 12.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on the Rate of Perceived Exertion Scale
The primary purpose is to observe the effect of supplementation on feelings of fatigue after exercise testing in the laboratory at Week 0, 4, 12. The scale ranges from 6 to 20 with 6 labeled as "no exertion" and 20 labeled as "maximal exertion". All values are subjective and based on an individual's perception. For the purposes of this study, a value ranged as close to 20 as possible to ensure maximal effort is achieved.
Measured: 12 weeks (84 days)
Secondary outcomes (40)
Effect of IronAid IPS on Glucose mg/dL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Urea Nitrogen (BUN) mg/Dl
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Creatinine mg/Dl
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on eGFR Non-Afr. American mL/min/1.73m2
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on eGFR African American mL/min/1.73m2
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on BUN/Creatinine Ratio calculated
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Sodium mmol/L
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Potassium mmol/L
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Chloride mmol/L
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Carbon Dioxide mmol/L
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Calcium mg/Dl
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Protein, Total g/Dl
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Albumin g/dL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Globulin g/Dl
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Albumin/Globulin Ratio calculated
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Bilirubin, Total mg/Dl
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Alkaline Phosphatase U/L
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Aspartate Aminotransferase U/L
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Alanine Aminotransferase U/L
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on White Blood Cell Count thousand/uL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Red Blood Cell Count million/uL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Hemoglobin g/dL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Hematocrit %
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on MCV fL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on MCH pg
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on MCHC g/dL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on RDW %
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Platelet Count thousand/uL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on MPV fL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Absolute Neutrophils cells/uL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Absolute Lymphocytes cells/uL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Absolute Monocytes cells/uL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Absolute Eosinophils cells/uL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Absolute Basophils cells/uL
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Neutrophils %
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Lymphocytes %
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Monocytes %
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Eosinophils %
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on Basophils %
The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period.
Measured: 12 weeks (84 days)
Effect of IronAid IPS on the Short form (36) Health Survey
The secondary purpose is to assess the effects of ingesting the supplement on the immune system by means of completing this survey at Week 0, 4, 8 and 12.
Measured: Week 0, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start29 Nov 2016
- Primary completion11 Nov 2017
- Study completion11 Nov 2017
Why it stopped: Unable to recruit qualified participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: placebo, 30mg dose
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mary Hardin-Baylor
- Sponsor type
- University, hospital or other
- Collaborators
- ChemiNutra
- Responsible party
- Sponsor
- Investigators
- Lemuel W Taylor, PhD, Principal investigator, UMHB Human Performance Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523455
- Sponsor's protocol ID
- IRA-1
- Status last verified
- Aug 2018
- First submitted
- 1 May 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training
- ClinicalTrials.gov ID
- NCT03523455
- Acronym / sponsor ID
- IRA-1
- Conditions
- Iron-deficiency
- Keywords
- Iron, Exercise Performance, Fatigue
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit qualified participants
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Mary Hardin-BaylorUniversity, hospital or other
- Collaborators
- ChemiNutra
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 11 Nov 2017 (actual)
- Study completion
- 11 Nov 2017 (actual)
- First posted
- 14 May 2018 (actual)
- 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.
Participants are required to undergo a screening and qualification before beginning the study. Once qualified, baseline testing is completed in the laboratory. This testing includes: body composition measurements, a blood draw, questionnaires, a VO2 max test, and a time to exhaustion trial. This testing is repeated during week 4 and week 12. At week 8, subjects complete a blood draw and questionnaires only. During the 12 week period, participants will follow an endurance exercise program in which they will train 4 days per week. This is a double-blind study in which participants are randomized into either the placebo or supplement group. They are instructed to ingest the supplement once a day at breakfast. Diet logs are also monitored throughout the duration of the study with the restriction of no red meat.
Detailed description
Subjects expressing interest in participating in this study, were interviewed in person to determine whether they appeared to qualify to participate in the study. If they met eligibility criteria, they were invited to attend an entry/familiarization session. During this session, they completed personal and medical histories which were reviewed to determine whether they met eligibility criteria. Once meeting entry criteria, they were familiarized to the study protocol via a verbal and written explanation outlining the study design. Subjects then read and signed the Informed Consent Statements after the study details were explained. Subjects then perform the exercise protocol in which they must have completed in order to qualify for the study.
Subjects were asked to perform a VO2 Max test using the Bruce protocol. Following the VO2 Max test, subjects were given a rest period of 20 minutes before starting the Time to Exhaustion (TTE) trial run. This session familiarized subjects with the exercise protocol preparing them for the qualification testing session. Subjects then returned to the lab in a 12 hour fasted state and completed a VO2max test. If a 42 ml/kg/min or above was achieved subjects were then allowed to complete the 20 minute TTE test. After completion of the TTE, a blood draw was done to access the subject's iron levels. Once results for iron levels returned at a 90 or below subjects were given an appointment time to perform baseline assessments and testing sessions.
Baseline testing (Week 0), Week 8 and Week 12 took place on the 8th or 9th day after the subject's menstrual cycle. Subjects returned to the lab in a 12 hour fasted state, with no strenuous workouts done 48 hours prior to testing. Subjects had their height and weight measured, filled out questionnaires, completed a DEXA scan and InBody to establish current body composition, afterwards having their heart rate and blood pressure assessed. At this point subjects were instructed to lay on a table for their blood draw. Once the blood draw was done, subjects completed a VO2 Max test using the Bruce protocol. Following the VO2 Max testing, subjects filled out 2 questionnaires and were given a rest period of 20 minutes before starting the Time to Exhaustion (TTE) trial run. During the rest period subjects were given a snack to ingest (banana or apple) and consumed the same snack at each testing session. Approximately 12 minutes prior to the TTE subjects filled out a questionnaire. During the TTE run subjects were able to control and see the speed at which they ran but were blinded to the time passed along with the distance completed. After the 20 minutes, the treadmill stopped, distance, heart rate and blood pressure were measured. Afterwards, subjects filled out post exercise questionnaires. At week 0, after all exercise testing was completed, subjects were assigned to a group (either placebo or active) and instructed to ingest 1 capsule per day. A workout log was also provided to each subject, who would return to the lab every Friday with their workout log to access exercise compliance.
At week 4, subjects returned to the lab on the 8th or 9th day after their menstrual cycle to have a blood draw completed to access blood marker variables in addition to questionnaires.
Diet logs were keep throughout the duration of the study and were monitored by lab staff.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two groups: placebo, 30mg dose
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Other: Sugar PillMaltodextrin (matches the weight of the active treatment) Taken once each day after breakfast, but before lunch. |
| Iron Aid IPS (Iron Protein Succinylate) | Active comparator | Dietary Supplement: Iron Aid IPS (Iron Protein Succinylate)IronAid Iron Protein Succinylate 30 mg Taken once each day after breakfast, but before lunch. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- I am willing to and provide written and dated informed consent form to participate in the study;
- I am female 18-30 years of age;
- I am willing and able to comply with protocol;
- My VO2 max is in compliance with age range (42 ml/kg/min);
- I have not used or consumed any prescription drugs or supplements that could potentially confound the results of the current supplement;
Key exclusion criteria (13 listed)
- I use tobacco products or have quit within the past 6 months;
- I am currently pregnant, plan on becoming pregnant, or become pregnant during the duration of the study;
- I have given birth or been pregnant the past year;
- I am currently taking or have taken any oral contraception within the past 6 months;
- I have difficulty giving blood;
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 |
|---|---|---|
| Iron Aid IPS (Iron Protein Succinylate)Taken orally in capsule form | Dietary supplement | Iron Aid IPS (Iron Protein Succinylate) |
| Sugar PillTaken orally in capsule form | Other | Sugar Pill |
Primary outcome
Effect of IronAid IPS on Iron mcg/dL
Time frame: 12 weeks (84 days)
The primary purpose is to observe the effect of supplementation on fasting total iron levels prior to and after the supplementation period.
Effect of IronAid IPS on Ferritin ng/mL
Time frame: 12 weeks (84 days)
The primary purpose is to observe the effect of supplementation on ferritin levels prior to and after the supplementation period.
Effect of IronAid IPS on the Exercise Induced Feeling Inventory
Time frame: 12 weeks (84 days)
The primary purpose is to observe the effect of supplementation on feelings of fatigue prior to and after exercise testing in the laboratory at Week 0, 4, 12.
Effect of IronAid IPS on the Rate of Perceived Exertion Scale
Time frame: 12 weeks (84 days)
The primary purpose is to observe the effect of supplementation on feelings of fatigue after exercise testing in the laboratory at Week 0, 4, 12. The scale ranges from 6 to 20 with 6 labeled as "no exertion" and 20 labeled as "maximal exertion". All values are subjective and based on an individual's perception. For the purposes of this study, a value ranged as close to 20 as possible to ensure maximal effort is achieved.
40 secondary outcomes
Effect of IronAid IPS on Glucose mg/dL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Urea Nitrogen (BUN) mg/Dl
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Creatinine mg/Dl
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on eGFR Non-Afr. American mL/min/1.73m2
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on eGFR African American mL/min/1.73m2
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on BUN/Creatinine Ratio calculated
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Sodium mmol/L
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Potassium mmol/L
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Chloride mmol/L
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Carbon Dioxide mmol/L
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Calcium mg/Dl
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Protein, Total g/Dl
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Albumin g/dL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Globulin g/Dl
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Albumin/Globulin Ratio calculated
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Bilirubin, Total mg/Dl
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Alkaline Phosphatase U/L
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Aspartate Aminotransferase U/L
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Alanine Aminotransferase U/L
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on White Blood Cell Count thousand/uL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Red Blood Cell Count million/uL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Hemoglobin g/dL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Hematocrit %
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on MCV fL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on MCH pg
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on MCHC g/dL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on RDW %
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Platelet Count thousand/uL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on MPV fL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Absolute Neutrophils cells/uL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Absolute Lymphocytes cells/uL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Absolute Monocytes cells/uL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Absolute Eosinophils cells/uL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Absolute Basophils cells/uL
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Neutrophils %
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Lymphocytes %
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Monocytes %
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Eosinophils %
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on Basophils %
Time frame: 12 weeks (84 days)
Effect of IronAid IPS on the Short form (36) Health Survey
Time frame: Week 0, 4, 8, and 12
Results and safety
The study was stopped early (reason given: Unable to recruit qualified participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Lemuel W Taylor, PhD principal investigator
UMHB Human Performance Lab
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 Aid IPS (Iron Protein Succinylate) and Sugar Pill in people with Iron-deficiency, run by University of Mary Hardin-Baylor 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 11 inclusion and 13 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: stopped early, as of the sponsor's last update on 8 Aug 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. 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 was stopped early (reason given: Unable to recruit qualified participants). Results are not available in the source record.
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?
Effect of IronAid IPS on Iron mcg/dL (time frame: 12 weeks (84 days)). 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?
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 8 Aug 2018.