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Meals to Improve Absorption of Iron Supplements

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Pennington Biomedical Research Center

Status

Completed

Conditions

Iron Deficiency Anemia
Iron-deficiency
Iron Deficiency Anemia Treatment

Treatments

Other: Iron supplement with a lunch meal containing plant-based alternative
Other: Iron supplement with a lunch meal containing beef

Study type

Interventional

Funder types

Other

Identifiers

NCT04793906
PBRC 2022-036

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

59 participants in 2 patient groups

Beef
Experimental group
Treatment:
Other: Iron supplement with a lunch meal containing beef
Plant-based alternative
Experimental group
Treatment:
Other: Iron supplement with a lunch meal containing plant-based alternative

Trial contacts and locations

1

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Central trial contact

Stephen Hennigar, PhD

Data sourced from clinicaltrials.gov

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