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

Iron Deficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739907
• Other study ID #: AGL2009-11437
• Status: Completed
• Phase: N/A
• First received: November 20, 2012
• Last updated: June 12, 2014
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: October 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Other:
• Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Research Council, Spain

References & Publications (6)

Blanco-Rojo R, Toxqui L, López-Parra AM, Baeza-Richer C, Pérez-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. — View Citation

Toxqui L, Blanco-Rojo R, Wright I, Pérez-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/nu51 — View Citation

Toxqui L, Pérez-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. — View Citation

Toxqui L, Pérez-Granados AM, Blanco-Rojo R, Wright I, González-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 — View Citation

Toxqui L, Pérez-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: — View Citation

Wright I, Blanco-Rojo R, Fernández MC, Toxqui L, Moreno G, Pérez-Granados AM, de la Piedra C, Remacha ÁF, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ferritin changes over 16 weeks		16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)	No
Secondary	Haemoglobin changes over 16 weeks		16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)	No
Secondary	Total erythrocytes changes over 16 weeks		16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)	No
Secondary	Haematocrit changes over 16 weeks		16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)	No
Secondary	Mean corpuscular volume changes over 16 weeks		16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)	No
Secondary	Red blood cell distribution width changes over 16 weeks		16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)	No
Secondary	Serum iron changes over 16 weeks		16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)	No
Secondary	Serum transferrin changes over 16 weeks		16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)	No
Secondary	Transferrin saturation changes over 16 weeks		16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)	No
Secondary	Soluble transferrin receptor changes over 16 weeks		16 weeks (Measures at 0, 8, and 16 weeks)	No
Secondary	25-hydroxyvitamin D changes over 16 weeks		16 weeks (Measures at 0, 8, and 16 weeks)	No
Secondary	Procollagen type 1 N-terminal propeptide (P1NP) changes over 16 weeks		16 weeks (measures at 0, 8 and 16 weeks)	No
Secondary	Cross-linked N-telopeptides of type I collagen (NTX) changes over 16 weeks		16 weeks (measures at 0, 8 and 16 weeks	No
Secondary	Parathormone (PTH) changes over 16 weeks		16 weeks (measures at 0, 8 and 16 weeks	No
Secondary	Total cholesterol changes over 16 weeks		16 weeks (Measures at 0, 8 and 16 weeks	No
Secondary	LDL-cholesterol changes over 16 weeks		16 weeks (Measures at 0, 8 and 16 weeks)	No
Secondary	HDL-cholesterol changes over 16 weeks		16 weeks (Measures at 0, 8 and 16 weeks)	No
Secondary	Triglycerides changes over 16 weeks		16 weeks (Measures at 0, 8 and 16 weeks)	No
Secondary	Systolic blood pressure changes over 16 weeks		16 weeks (Measures at 0, 8 and 16 weeks)	No
Secondary	Diastolic blood pressure changes over 16 weeks		16 weeks (Measures at 0, 8 and 16 weeks)	No
Secondary	glucose changes over 16 weeks		16 weeks (Measures at 0, 8 and 16 weeks)	No