FeDrink: Iron Fortified Beverages and Application in Women Predisposed to Anemia

Sponsor

National Research Council, Spain (Other)

Overall Status

Completed

CT.gov ID

NCT01135576

Collaborator

Ministry of Science and Innovation, Spain (Other), Grupo Leche Pascual (Other), Madrid Salud, Madrid, Spain (Other)

122

Enrollment

Arms

5.9

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Iron-deficiency Anemia	Dietary Supplement: non-fortified fruit juices consumed as part of the usual diet Dietary Supplement: Iron fortified fruit juice	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo juices Consumption of non-iron fortified fruit juices as part of the usual diet	Dietary Supplement: non-fortified fruit juices consumed as part of the usual diet
Experimental: Iron fortified fruit juices Consumption of iron fortified fruit juices as part of the usual diet	Dietary Supplement: Iron fortified fruit juice Consumption of micronized iron pyrophosphate supplemented fruit juices as part of the usual diet

Arm

Intervention/Treatment

Placebo Comparator: Placebo juices

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

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

Experimental: Iron fortified fruit juices

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

Dietary Supplement: Iron fortified fruit juice

Consumption of micronized iron pyrophosphate supplemented fruit juices as part of the usual diet

Outcome Measures

Primary Outcome Measures

Serum Ferritin [monitored during 16 weeks]

Secondary Outcome Measures

Serum transferrin [monitored during 16 weeks]
Hemoglobin [monitored during 16 weeks]
serum iron [monitored during 16 weeks]
transferrin saturation [monitored during 16 weeks]
soluble transferrin receptor [monitored during 16 weeks]
zinc protoporphyrin [monitored during 16 weeks]
Total red blood cells [monitored during 16 weeks]
Hematocrit [monitored during 16 weeks]
Mean corpuscular volume [monitored during 16 weeks]
Red blood cell distribution width [monitored during 16 weeks]
25-hydroxycholecalciferol [monitored during 16 weeks]
alkaline phosphatase bone-isoenzyme (ALP) [monitored during 16 weeks]
serum cross-linked N-telopeptide of type I collagen (NTx) [monitored during 16 weeks]
Total cholesterol [monitored during 16 weeks]
HDL-cholesterol [monitored during 16 weeks]
LDL-cholesterol [monitored during 16 weeks]
Glucose [monitored during 16 weeks]
Serum triacylglycerols [monitored during 16 weeks]
T-chol/HDL-chol [monitored during 16 weeks]
LDL-chol/HDL-chol [monitored during 16 weeks]
Systolic blood pressure [monitored during 16 weeks]
Diastolic blood pressure [monitored during 16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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