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

NCT01739907 | Completed

• 1 other identifier: AGL2009-11437
• Study Type: interventional
• Target: 109
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Iron Deficiency

Keywords

Iron deficiency; Menstruating women; Vitamin D; Functional food

Outcome Measures

Primary Outcomes (1)

• Ferritin changes over 16 weeks

  16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)

Secondary Outcomes (20)

• 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)

Study Arms (2)

Iron-fortified dairy product

EXPERIMENTAL

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

Iron and vitamin D dairy product

EXPERIMENTAL

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

Interventions

Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women OTHER

Iron and vitamin D dairy product; Iron-fortified dairy product

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Council, Spain: lead

Related Publications (6)

• 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.

  PMID: 24663082 BACKGROUND

• 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.

  PMID: 23813442 BACKGROUND

• 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.

  PMID: 24219374 RESULT

• 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.

  PMID: 23771807 RESULT

• 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.

  PMID: 24317556 RESULT

• 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.

  PMID: 24886470 RESULT

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific researcher

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: December 4, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 13, 2014

Record last verified: 2012-11