Clinical trial NCT01739907: Iron-fortified Flavoured Skimmed Milk With or Without Vitamin D in Iron Deficient Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Keywords: Iron deficiency
Menstruating women
Vitamin D
Functional food
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
First posted: 2012-12-04
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Ferritin changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Secondary outcomes:
measure: Haemoglobin changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
measure: Total erythrocytes changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
measure: Haematocrit changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
measure: Mean corpuscular volume changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
measure: Red blood cell distribution width changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
measure: Serum iron changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
measure: Serum transferrin changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
measure: Transferrin saturation changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
measure: Soluble transferrin receptor changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 8, and 16 weeks)
measure: 25-hydroxyvitamin D changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 8, and 16 weeks)
measure: Procollagen type 1 N-terminal propeptide (P1NP) changes over 16 weeks
timeFrame: 16 weeks (measures at 0, 8 and 16 weeks)
measure: Cross-linked N-telopeptides of type I collagen (NTX) changes over 16 weeks
timeFrame: 16 weeks (measures at 0, 8 and 16 weeks
measure: Parathormone (PTH) changes over 16 weeks
timeFrame: 16 weeks (measures at 0, 8 and 16 weeks
measure: Total cholesterol changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 8 and 16 weeks
measure: LDL-cholesterol changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 8 and 16 weeks)
measure: HDL-cholesterol changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 8 and 16 weeks)
measure: Triglycerides changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 8 and 16 weeks)
measure: Systolic blood pressure changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 8 and 16 weeks)
measure: Diastolic blood pressure changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 8 and 16 weeks)
measure: glucose changes over 16 weeks
timeFrame: 16 weeks (Measures at 0, 8 and 16 weeks)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.