Clinical trial NCT04793906: Meals to Improve Absorption of Iron Supplements
Official title: Meals to Improve Absorption of Iron Supplements and Iron Status in Iron Deficient Women of Reproductive Age: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Iron Deficiency Anemia
Iron Deficiency Anemia Treatment
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the targeted objectives of Healthy People 2020 is to reduce iron deficiency among women of reproductive age (WRA). Consuming foods rich in iron and/or oral iron supplementation is typically recommended to improve iron status; however, global rates of iron deficiency remain high. Thus, nutritional strategies to improve/maintain iron status are warranted. Dietary iron is found in two different forms: heme and non-heme iron. Non-heme iron is found in plant-based sources and is commonly used as a supplement and food fortificant. Absorption of non-heme iron is low compared to heme iron, which is found in animal sources, such as beef. Studies have also demonstrated that beef contains an unidentified factor that stimulates the absorption of non-heme iron. The primary objective of the proposed study is to determine the effects of incorporating daily meals containing beef or plant-based alternative with or without an iron supplement on indicators of iron status in iron-deficient WRA.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) falls within the normal weight or overweight range (18.5-29.9 kg/m\^2)
* Low iron stores (serum ferritin \<25 μg/L)
* Willing to refrain from smoking and \>2 alcoholic drinks/week for the duration of the study period
* Willing to refrain from vitamin and mineral supplementation for the duration of the study

Exclusion Criteria:

* Currently smoking or vaping
* Currently taking a medication that interferes with micronutrient metabolism
* Unwilling to refrain from vitamin and mineral supplementation for the duration of the study
* Restrictive diets (i.e., vegan or vegetarian diets)
* Metabolic or cardiovascular abnormalities (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
* History of any disease or abnormality of the gastrointestinal tract including, but not limited to, diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis; or previous gastrointestinal surgery
* Blood donation within 4 months of beginning the study
* Abnormal blood clotting

Primary outcomes:
measure: Iron status
timeFrame: Change from day 0 and day 56
Secondary outcomes:
measure: Profile of Mood States (POMS)
timeFrame: Change from day 0 and day 56
measure: Appetite
timeFrame: Change from day 0 and day 56
measure: Weight
timeFrame: Change from day 0 and day 56
measure: Body composition
timeFrame: Change from day 0 and day 56
measure: Blood pressure
timeFrame: Change from day 0 and day 56
measure: Metabolic biomarkers
timeFrame: Change from day 0 and day 56
measure: Plasma zinc
timeFrame: Change from day 0 and day 56
measure: Plasma vitamin B-12
timeFrame: Change from day 0 and day 56
measure: Plasma choline
timeFrame: Change from day 0 and day 56
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References: