Iron-fortified Flavoured Skimmed Milk With or Without Vitamin D in Iron Deficient Women

Iron deficiency and vitamin D deficiencies are common in menstruating women. The present assay studied the influence of the consumption of a flavoured skimmed milk with iron (iron pyrophosphate) or with iron and vitamin D3 in iron deficient women on:

• Iron metabolism
• Biomarkers of bone remodelling
• Cardiovascular risk indexes

Study Overview

• Status: Completed
• Conditions: Iron Deficiency
• Intervention / Treatment: Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Non-smoker or smokers of ≤ 3 cigarettes/day
• Non-pregnant
• non-breast-feeding
• Serum ferritin <30ng/mL
• Haemoglobin ≥11g/dL

Exclusion Criteria:

• Amenorrhea
• Menopause
• Any known health problems likely to influence iron status including iron-metabolism-related diseases (iron deficiency anaemia, thalassaemia, haemochromatosis)
• Chronic gastric diseases (inflammatory bowel disease, Crohn disease, gastric ulcers, celiac disease, hemorrhagic diseases)
• Renal disease or allergy to some of the components of the assay diary product.
• Blood donors
• Have regularly consumed iron or ascorbic acid supplements within the four months prior to participating in the intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iron-fortified dairy product; Consumption of an iron-fortified flavoured skimmed milk as part of the usual diet	Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women
Experimental: Iron and vitamin D dairy product; Consumption of an iron and vitamin D fortified flavoured skimmed milk as part of the usual diet	Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ferritin changes over 16 weeks	16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
Haemoglobin changes over 16 weeks	16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Total erythrocytes changes over 16 weeks	16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Haematocrit changes over 16 weeks	16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Mean corpuscular volume changes over 16 weeks	16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Red blood cell distribution width changes over 16 weeks	16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Serum iron changes over 16 weeks	16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Serum transferrin changes over 16 weeks	16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Transferrin saturation changes over 16 weeks	16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Soluble transferrin receptor changes over 16 weeks	16 weeks (Measures at 0, 8, and 16 weeks)
25-hydroxyvitamin D changes over 16 weeks	16 weeks (Measures at 0, 8, and 16 weeks)
Procollagen type 1 N-terminal propeptide (P1NP) changes over 16 weeks	16 weeks (measures at 0, 8 and 16 weeks)
Cross-linked N-telopeptides of type I collagen (NTX) changes over 16 weeks	16 weeks (measures at 0, 8 and 16 weeks
Parathormone (PTH) changes over 16 weeks	16 weeks (measures at 0, 8 and 16 weeks
Total cholesterol changes over 16 weeks	16 weeks (Measures at 0, 8 and 16 weeks
LDL-cholesterol changes over 16 weeks	16 weeks (Measures at 0, 8 and 16 weeks)
HDL-cholesterol changes over 16 weeks	16 weeks (Measures at 0, 8 and 16 weeks)
Triglycerides changes over 16 weeks	16 weeks (Measures at 0, 8 and 16 weeks)
Systolic blood pressure changes over 16 weeks	16 weeks (Measures at 0, 8 and 16 weeks)
Diastolic blood pressure changes over 16 weeks	16 weeks (Measures at 0, 8 and 16 weeks)
glucose changes over 16 weeks	16 weeks (Measures at 0, 8 and 16 weeks)

Collaborators and Investigators

• Sponsor: National Research Council, Spain

Publications and helpful links

General Publications

• Blanco-Rojo R, Toxqui L, Lopez-Parra AM, Baeza-Richer C, Perez-Granados AM, Arroyo-Pardo E, Vaquero MP. Influence of diet, menstruation and genetic factors on iron status: a cross-sectional study in Spanish women of childbearing age. Int J Mol Sci. 2014 Mar 6;15(3):4077-87. doi: 10.3390/ijms15034077.
• Wright I, Blanco-Rojo R, Fernandez MC, Toxqui L, Moreno G, Perez-Granados AM, de la Piedra C, Remacha AF, Vaquero MP. Bone remodelling is reduced by recovery from iron-deficiency anaemia in premenopausal women. J Physiol Biochem. 2013 Dec;69(4):889-96. doi: 10.1007/s13105-013-0266-3. Epub 2013 Jun 28.
• Toxqui L, Perez-Granados AM, Blanco-Rojo R, Wright I, Gonzalez-Vizcayno C, Vaquero MP. Effects of an iron or iron and vitamin D-fortified flavored skim milk on iron metabolism: a randomized controlled double-blind trial in iron-deficient women. J Am Coll Nutr. 2013;32(5):312-20. doi: 10.1080/07315724.2013.826116.
• Toxqui L, Perez-Granados AM, Blanco-Rojo R, Wright I, de la Piedra C, Vaquero MP. Low iron status as a factor of increased bone resorption and effects of an iron and vitamin D-fortified skimmed milk on bone remodelling in young Spanish women. Eur J Nutr. 2014;53(2):441-8. doi: 10.1007/s00394-013-0544-4. Epub 2013 Jun 16.
• Toxqui L, Blanco-Rojo R, Wright I, Perez-Granados AM, Vaquero MP. Changes in blood pressure and lipid levels in young women consuming a vitamin D-fortified skimmed milk: a randomised controlled trial. Nutrients. 2013 Dec 5;5(12):4966-77. doi: 10.3390/nu5124966.
• Toxqui L, Perez-Granados AM, Blanco-Rojo R, Wright I, Vaquero MP. A simple and feasible questionnaire to estimate menstrual blood loss: relationship with hematological and gynecological parameters in young women. BMC Womens Health. 2014 May 30;14:71. doi: 10.1186/1472-6874-14-71.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: November 28, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Estimate): June 13, 2014
• Last Update Submitted That Met QC Criteria: June 12, 2014
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Vitamin D; Iron deficiency; Functional food; Menstruating women
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: AGL2009-11437