Iron DeficiencyNCT01739907
Iron-fortified Flavoured Skimmed Milk With or Without Vitamin D in Iron Deficient Women
A study testing Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women in people with Iron Deficiency, run by National Research Council, Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker or smokers of ≤ 3 cigarettes/day
- Non-pregnant
- non-breast-feeding
- Serum ferritin <30ng/mL
- Haemoglobin ≥11g/dL
Who cannot join
- 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.
About this study
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
- Being tested
- Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women
- Keywords
- Iron deficiency, Menstruating women, Vitamin D, Functional food
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient womenOther
| Study group | Role | What they receive |
|---|---|---|
| Iron-fortified dairy product | Experimental | Consumption of an iron-fortified flavoured skimmed milk as part of the usual diet Receives: 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 Receives: Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferritin changes over 16 weeks
Measured: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Secondary outcomes (20)
Haemoglobin changes over 16 weeks
Measured: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Total erythrocytes changes over 16 weeks
Measured: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Haematocrit changes over 16 weeks
Measured: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Mean corpuscular volume changes over 16 weeks
Measured: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Red blood cell distribution width changes over 16 weeks
Measured: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Serum iron changes over 16 weeks
Measured: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Serum transferrin changes over 16 weeks
Measured: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Transferrin saturation changes over 16 weeks
Measured: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Soluble transferrin receptor changes over 16 weeks
Measured: 16 weeks (Measures at 0, 8, and 16 weeks)
25-hydroxyvitamin D changes over 16 weeks
Measured: 16 weeks (Measures at 0, 8, and 16 weeks)
Procollagen type 1 N-terminal propeptide (P1NP) changes over 16 weeks
Measured: 16 weeks (measures at 0, 8 and 16 weeks)
Cross-linked N-telopeptides of type I collagen (NTX) changes over 16 weeks
Measured: 16 weeks (measures at 0, 8 and 16 weeks
Parathormone (PTH) changes over 16 weeks
Measured: 16 weeks (measures at 0, 8 and 16 weeks
Total cholesterol changes over 16 weeks
Measured: 16 weeks (Measures at 0, 8 and 16 weeks
LDL-cholesterol changes over 16 weeks
Measured: 16 weeks (Measures at 0, 8 and 16 weeks)
HDL-cholesterol changes over 16 weeks
Measured: 16 weeks (Measures at 0, 8 and 16 weeks)
Triglycerides changes over 16 weeks
Measured: 16 weeks (Measures at 0, 8 and 16 weeks)
Systolic blood pressure changes over 16 weeks
Measured: 16 weeks (Measures at 0, 8 and 16 weeks)
Diastolic blood pressure changes over 16 weeks
Measured: 16 weeks (Measures at 0, 8 and 16 weeks)
glucose changes over 16 weeks
Measured: 16 weeks (Measures at 0, 8 and 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Responsible party
- Principal investigator, M Pilar Vaquero, National Research Council, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739907
- Sponsor's protocol ID
- AGL2009-11437
- Status last verified
- Nov 2012
- First submitted
- 20 Nov 2012
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24663082Wright 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.
PubMed 23813442Toxqui 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.
PubMed 24219374Toxqui 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.
PubMed 23771807Toxqui 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.
PubMed 24317556Toxqui 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.
PubMed 24886470
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron-fortified Flavoured Skimmed Milk With or Without Vitamin D in Iron Deficient Women
- ClinicalTrials.gov ID
- NCT01739907
- Acronym / sponsor ID
- AGL2009-11437
- Conditions
- Iron Deficiency
- Keywords
- Iron deficiency, Menstruating women, Vitamin D, Functional food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron-fortified dairy product | Experimental | Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient womenConsumption of an iron-fortified flavoured skimmed milk as part of the usual diet |
| Iron and vitamin D dairy product | Experimental | Other: Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient womenConsumption of an iron and vitamin D fortified flavoured skimmed milk as part of the usual diet |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smoker or smokers of ≤ 3 cigarettes/day
- Non-pregnant
- non-breast-feeding
- Serum ferritin <30ng/mL
- Haemoglobin ≥11g/dL
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Ferritin changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
20 secondary outcomes
Haemoglobin changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Total erythrocytes changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Haematocrit changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Mean corpuscular volume changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Red blood cell distribution width changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Serum iron changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Serum transferrin changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Transferrin saturation changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
Soluble transferrin receptor changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 8, and 16 weeks)
25-hydroxyvitamin D changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 8, and 16 weeks)
Procollagen type 1 N-terminal propeptide (P1NP) changes over 16 weeks
Time frame: 16 weeks (measures at 0, 8 and 16 weeks)
Cross-linked N-telopeptides of type I collagen (NTX) changes over 16 weeks
Time frame: 16 weeks (measures at 0, 8 and 16 weeks
Parathormone (PTH) changes over 16 weeks
Time frame: 16 weeks (measures at 0, 8 and 16 weeks
Total cholesterol changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 8 and 16 weeks
LDL-cholesterol changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 8 and 16 weeks)
HDL-cholesterol changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 8 and 16 weeks)
Triglycerides changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 8 and 16 weeks)
Systolic blood pressure changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 8 and 16 weeks)
Diastolic blood pressure changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 8 and 16 weeks)
glucose changes over 16 weeks
Time frame: 16 weeks (Measures at 0, 8 and 16 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
- Background: PubMed 24663082Blanco-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.
- Background: PubMed 23813442Wright 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.
- Results publication: PubMed 24219374Toxqui 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.
- Results publication: PubMed 23771807Toxqui 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.
- Results publication: PubMed 24317556Toxqui 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.
- Results publication: PubMed 24886470Toxqui 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women in people with Iron Deficiency, run by National Research Council, Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ferritin changes over 16 weeks (time frame: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01739907, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014.