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Iron-deficiency AnemiaFeDrinkNCT01135576

Iron Fortified Beverages and Application in Women Predisposed to Anemia

A study testing non-fortified fruit juices consumed as part of the usual diet and Iron fortified fruit juice in people with Iron-deficiency Anemia, run by National Research Council, Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of the study is to know if consumption of an iron fortified fruit juice containing micronized iron pyrophosphate, is useful to increase iron status in women predisposed to iron deficiency anemia. A secondary objective is to know if consumption of this iron fortified fruit juice modifies bone remodelling. 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 Anemia
What is being tested?
non-fortified fruit juices consumed as part of the usual diet and Iron fortified fruit juice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
No sites listed yet
Study dates
Nov 2008to May 2009
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

  • Women
  • non-smoker
  • non-pregnant
  • non-breastfeeding
  • serum ferritin <40 ng/ml
  • hemoglobin>=11g/dl

Who cannot join

  • Serum Ferritin >=40 ng/ml
  • Hemoglobin <11g/dl
  • Amenorrhea
  • Menopause
  • Iron deficiency anemia
  • Thalassemia
Show all 13Show fewer
  • Hemochromatosis
  • Blood donors
  • Chronic gastric diseases
  • Renal diseases
  • Eating disorders
  • Allergy to any component of the study juices
  • Consumption of iron or ascorbic acid supplements within 4 month prior to participating in the study

About this study

  • The objective of the study is to know if consumption of an iron fortified fruit juice containing micronized iron pyrophosphate, is useful to increase iron status in women predisposed to iron deficiency anemia.
  • A secondary objective is to know if consumption of this iron fortified fruit juice modifies bone remodelling.
Being tested
non-fortified fruit juices consumed as part of the usual diet, Iron fortified fruit juice
Keywords
Ferric pyrophosphate, Fortification, Fruit juice, Functional food, Bioavailability, iron status, Women, iron-deficiency anemia
Medical subject headings
Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non-fortified fruit juices consumed as part of the usual dietDietary supplement

  • Iron fortified fruit juiceDietary supplement

    Consumption of micronized iron pyrophosphate supplemented fruit juices as part of the usual diet

Study groups in NCT01135576
Study groupRoleWhat they receive
Placebo juicesPlacebo comparatorConsumption of non-iron fortified fruit juices as part of the usual diet
Receives: Dietary Supplement: non-fortified fruit juices consumed as part of the usual diet
Iron fortified fruit juicesExperimentalConsumption of iron fortified fruit juices as part of the usual diet
Receives: Dietary Supplement: Iron fortified fruit juice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Ferritin

    Measured: monitored during 16 weeks

Secondary outcomes (22)

  1. Serum transferrin

    Measured: monitored during 16 weeks

  2. Hemoglobin

    Measured: monitored during 16 weeks

  3. serum iron

    Measured: monitored during 16 weeks

  4. transferrin saturation

    Measured: monitored during 16 weeks

  5. soluble transferrin receptor

    Measured: monitored during 16 weeks

  6. zinc protoporphyrin

    Measured: monitored during 16 weeks

  7. Total red blood cells

    Measured: monitored during 16 weeks

  8. Hematocrit

    Measured: monitored during 16 weeks

  9. Mean corpuscular volume

    Measured: monitored during 16 weeks

  10. Red blood cell distribution width

    Measured: monitored during 16 weeks

  11. 25-hydroxycholecalciferol

    Measured: monitored during 16 weeks

  12. alkaline phosphatase bone-isoenzyme (ALP)

    Measured: monitored during 16 weeks

  13. serum cross-linked N-telopeptide of type I collagen (NTx)

    Measured: monitored during 16 weeks

  14. Total cholesterol

    Measured: monitored during 16 weeks

  15. HDL-cholesterol

    Measured: monitored during 16 weeks

  16. LDL-cholesterol

    Measured: monitored during 16 weeks

  17. Glucose

    Measured: monitored during 16 weeks

  18. Serum triacylglycerols

    Measured: monitored during 16 weeks

  19. T-chol/HDL-chol

    Measured: monitored during 16 weeks

  20. LDL-chol/HDL-chol

    Measured: monitored during 16 weeks

  21. Systolic blood pressure

    Measured: monitored during 16 weeks

  22. Diastolic blood pressure

    Measured: monitored during 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2010 (estimated)
  2. Study startNov 2008
  3. Primary completionJan 2009
  4. Study completionMay 2009

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01135576
Sponsor's protocol ID
AGL2006/09519/ALI
Acronym
FeDrink
Status last verified
Dec 2012
First submitted
28 May 2010
Last updated
24 Dec 2012
Results posted
No
Data monitoring committee
No

Publications

  • Navas-Carretero S, Perez-Granados AM, Schoppen S, Sarria B, Carbajal A, Vaquero MP. Iron status biomarkers in iron deficient women consuming oily fish versus red meat diet. J Physiol Biochem. 2009 Jun;65(2):165-74. doi: 10.1007/BF03179067.

    PubMed 19886395

  • Navas-Carretero S, Perez-Granados AM, Schoppen S, Vaquero MP. An oily fish diet increases insulin sensitivity compared to a red meat diet in young iron-deficient women. Br J Nutr. 2009 Aug;102(4):546-53. doi: 10.1017/S0007114509220794. Epub 2009 Feb 12.

    PubMed 19210857

  • Navas-Carretero S, Perez-Granados AM, Sarria B, Vaquero MP. Iron absorption from meat pate fortified with ferric pyrophosphate in iron-deficient women. Nutrition. 2009 Jan;25(1):20-4. doi: 10.1016/j.nut.2008.07.002. Epub 2008 Aug 26.

    PubMed 18752926

  • Navas-Carretero S, Perez-Granados AM, Sarria B, Carbajal A, Pedrosa MM, Roe MA, Fairweather-Tait SJ, Vaquero MP. Oily fish increases iron bioavailability of a phytate rich meal in young iron deficient women. J Am Coll Nutr. 2008 Feb;27(1):96-101. doi: 10.1080/07315724.2008.10719680.

    PubMed 18460487

  • Navas-Carretero S, Sarria B, Perez-Granados AM, Schoppen S, Izquierdo-Pulido M, Vaquero MP. A comparative study of iron bioavailability from cocoa supplemented with ferric pyrophosphate or ferrous fumarate in rats. Ann Nutr Metab. 2007;51(3):204-7. doi: 10.1159/000104138. Epub 2007 Jun 18.

    PubMed 17587790

  • Sarria B, Navas-Carretero S, Lopez-Parra AM, Perez-Granados AM, Arroyo-Pardo E, Roe MA, Teucher B, Vaquero MP, Fairweather-Tait SJ. The G277S transferrin mutation does not affect iron absorption in iron deficient women. Eur J Nutr. 2007 Feb;46(1):57-60. doi: 10.1007/s00394-006-0631-x. Epub 2007 Jan 5.

    PubMed 17206377

  • Navas-Carretero S, Pérez-Granados AM, Sarriá B, Schoppen S, Vaquero MP. Iron bioavailability from pate enriched with encapsulated ferric pyrophosphate or ferrous gluconate in rats. Food Sci Tech Int 13:159-163, 2007.

  • Toxqui L, De Piero A, Courtois V, Bastida S, Sanchez-Muniz FJ, Vaquero MP. [Iron deficiency and overload. Implications in oxidative stress and cardiovascular health]. Nutr Hosp. 2010 May-Jun;25(3):350-65. Spanish.

    PubMed 20593115

  • Blanco-Rojo R, Perez-Granados AM, Toxqui L, Zazo P, de la Piedra C, Vaquero MP. Relationship between vitamin D deficiency, bone remodelling and iron status in iron-deficient young women consuming an iron-fortified food. Eur J Nutr. 2013 Mar;52(2):695-703. doi: 10.1007/s00394-012-0375-8. Epub 2012 May 23.

    PubMed 22618893

  • Blanco-Rojo R, Perez-Granados AM, Toxqui L, Gonzalez-Vizcayno C, Delgado MA, Vaquero MP. Efficacy of a microencapsulated iron pyrophosphate-fortified fruit juice: a randomised, double-blind, placebo-controlled study in Spanish iron-deficient women. Br J Nutr. 2011 Jun;105(11):1652-9. doi: 10.1017/S0007114510005490. Epub 2011 Feb 8.

    PubMed 21303569

Questions about this trial

What is this clinical trial studying?

A study testing non-fortified fruit juices consumed as part of the usual diet and Iron fortified fruit juice in people with Iron-deficiency Anemia, 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 6 inclusion and 13 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 24 Dec 2012. 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. Some participants in this study may receive a placebo. 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?

Serum Ferritin (time frame: monitored during 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 NCT01135576, which also lists 10 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 24 Dec 2012.

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