Iron Fortified Beverages and Application in Women Predisposed to Anemia (FeDrink)

Higher Council for Scientific Research (CSIC)

Status: Completed

Conditions: Iron-deficiency Anemia

Treatments: Dietary Supplement: non-fortified fruit juices consumed as part of the usual diet; Dietary Supplement: Iron fortified fruit juice

Study type: Interventional

Funder types: Other

Identifiers

NCT01135576

AGL2006/09519/ALI

Details and patient eligibility

About

• The objective of the study is to know if consumption of an iron fortified fruit juice containing micronized iron pyrophosphate, is useful to increase iron status in women predisposed to iron deficiency anemia.
• A secondary objective is to know if consumption of this iron fortified fruit juice modifies bone remodelling.

Enrollment: 122 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women
• non-smoker
• non-pregnant
• non-breastfeeding
• serum ferritin <40 ng/ml
• hemoglobin>=11g/dl

Exclusion criteria

• Serum Ferritin >=40 ng/ml
• Hemoglobin <11g/dl
• Amenorrhea
• Menopause
• Iron deficiency anemia
• Thalassemia
• Hemochromatosis
• Blood donors
• Chronic gastric diseases
• Renal diseases
• Eating disorders
• Allergy to any component of the study juices
• Consumption of iron or ascorbic acid supplements within 4 month prior to participating in the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 2 patient groups, including a placebo group

Placebo juices

Placebo Comparator group

Description:

Consumption of non-iron fortified fruit juices as part of the usual diet

Treatment:

Dietary Supplement: non-fortified fruit juices consumed as part of the usual diet

Iron fortified fruit juices

Experimental group

Description:

Consumption of iron fortified fruit juices as part of the usual diet

Treatment:

Dietary Supplement: Iron fortified fruit juice