The Immediate and Long-term Effects of a Novel Marine-based Iron Supplement in Adult Females

Nutraceuticals Research Institute

Status

Active, not recruiting

Conditions

Anemia

Iron Deficiency (Without Anemia)

Iron Absorption

Treatments

Dietary Supplement: marine-based heme iron

Study type

Interventional

Funder types

Other

Identifiers

NCT07199244

24-04-2500

Details and patient eligibility

About

The goal of this study is to identify how well a fish-based iron supplement is absorbed and to learn how many, if any, digestive related side effects are caused by ingesting the supplement.

Full description

This is a single population observational-style trial with a 24-hour pharmacokinetic evaluation. A minimum of 44 healthy adult female consented participants will be screened and classified as low-iron levels or anemic. Both classifications receive active iron supplements as a single group. Participants will provide data on the outcome measures of safety, vital signs, iron levels from whole blood collection, and subjective experience. Blood collection will take place at baseline, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after ingestion. All data will be taken at baseline and again at day 56, after daily intake of the supplement.

Enrollment

61 patients

Sex

Female

Ages

21 to 42 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Provision of signed and dated informed consent form
Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
Lives within 100 miles of a NRI study site
Biological sex of woman; gender identification of female
Aged 21 to 42, inclusive
In luteal phase of menstrual cycle
Either low levels of iron or mild-moderate iron-deficiency (defined as screening hemoglobin of 12.0-14.0 g/dL or 8.0-11.9 g/dL, respectively)
Good general health as evidenced by medical history and screening metabolic panel and complete blood count (GMP & CBC)
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study
Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion criteria

A positive medical history of heart disease/cardiovascular disease, high blood pressure (140/90 or greater mmHg), kidney disease, hepatic impairment or disease, Type I or Type II diabetes, Irritable bowel disease/Irritable bowel syndrome (IBD/IBS), ulcerative colitis (UC), Crohn's disease or any other medical condition or diagnosis that the PI would deem exclusionary
A positive surgical medical history for any procedure that may impact iron status (i.e., gastric bypass, gastric pull-up (Roux-en-Y), short bowel syndrome, etc
A positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within five years before the screening visit.
A positive medical history of any gastrointestinal disease or illness
A positive history of any other gastrointestinal surgery that is known to alter or impact the digestion absorption of nutrients and or fluids
History of hospitalization or in-patient or out-patient treatment for alcohol dependence or drug addiction within the past two years
History of hospitalization or in-patient treatment for depression or any related condition within the past five years
Severe iron deficiency (defined as screening hemoglobin <8.0)
Pregnancy, trying to conceive, or breastfeeding
Currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has in the past year
Known allergic reactions to any components of the intervention
Positive COVID-19 test within 30 days of the study period
Obese, defined as BMI >35
Recent dramatic weight changes (10% change in body weight in the last 6 months)
Existing usage of an iron supplement in any form
Introducing a new investigational drug or other intervention within 60 days before the start of the study