Clinical trial NCT02683369: Low-dose Iron Supplementation and Markers of Iron Status Among Non-anemic, Iron-deficient Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Non-anemic Iron Deficiency
Keywords: Non-anemic Iron Deficiency, Iron Supplementation
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Pre-menopausal
2. Iron deficient without anemia (serum ferritin concentration \< 20 ug/L and a hemoglobin concentration \> 120 g/L)
3. Agree to continue with current diet and any dietary supplements
4. Able to understand and write English
5. Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects

Exclusion Criteria:

1. Daily supplementation of another iron supplement (other than multivitamin) currently or within past 2 weeks
2. Pregnant or breastfeeding females
3. History of alcohol, drug, or medication abuse
4. Known allergies to any substance in the study product
5. Donated blood in the past month or plan to do so at any time during the 8-week trial
6. Current diagnosis of inflammatory bowel disease (Crohn's or Ulcerative Colitis)
7. Taking medication that my interfere with the absorption of iron
8. Current tobacco smoker

Primary outcomes:
measure: Changes in Hemoglobin (Hgb) Level
timeFrame: Baseline and study end (8 weeks from baseline)
measure: Changes in Serum Ferritin (SF) Level
timeFrame: Baseline and study end (8 weeks from baseline)
measure: Changes in Soluble Transferrin Receptor (sTfR) Level
timeFrame: Baseline and study end (8 weeks from baseline)
measure: Changes in Total Body Iron Stores
timeFrame: Baseline and study end (8 weeks from baseline)
Secondary outcomes:
measure: Frequency and severity of self-reported constipation
timeFrame: Study end (8 weeks from baseline)
measure: Frequency and severity of self-reported diarrhea
timeFrame: Study end (8 weeks from baseline)
measure: Frequency and severity of self-reported nausea
timeFrame: Study end (8 weeks from baseline)
measure: Frequency and severity of self-reported vomiting
timeFrame: Study end (8 weeks from baseline)
measure: Frequency and severity of self-reported fatigue
timeFrame: Baseline and study end (8 weeks from baseline)
measure: Self-reported energy level
timeFrame: Baseline and study end (8 weeks from baseline)
measure: Supplement compliance assessed using participant daily diary
timeFrame: Study end (8 weeks from baseline)
measure: Adverse events
timeFrame: Study end (8 weeks from baseline)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Center for Integrative Medicine University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Chris D'Adamo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.