Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/06/2014
Date assigned
20/06/2014
Last edited
28/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Iron (Fe), zinc (Zn), and calcium (Ca) are essential nutrients for humans. Not having enough of these nutrients in our diet can have detrimental effects on, for example, growth, psychomotor development (development of mental and physical skills), immunity and reproduction. We think that giving a combined supplement providing a particular amount of Fe, Zn and Ca should improve the nutritional status (the balance between intake of nutrients and the amounts needed by the body) of these nutrients. Adolescence is one of the times in our lives where nutrition is particularly important as it’s a period of rapid physical and mental growth and sexual maturity. The major aim of this study is to find out the effect of combined Fe, Zn and Ca supplementation on the nutritional status of these nutrients in adolescents.

Who can participate?
Adolescents of between 16-17 years of age and classified as being at a certain stage of development (Tanner stage 5)

What does the study involve?
Patients are randomly allocated to one of four groups:
1. Calcium supplemented group (control group)
2. Calcium plus Fe supplemented group
3. Calcium plus Zn supplemented group
4. Calcium, Fe and Zn supplementation group
The study involves clinical, dietary, anthropometric (for example height and weight), and socio-demographic assessment before and after the supplementation period over 12 months.

What are the possible benefits and risks of participating?
The benefit is a full medical assessment to determine Fe and Ca nutritional status. Risks are not expected.

Where is the study run from?
The study runs in a low-income area of south-east Santiago and is managed by the Institute
of Nutrition and Food Technologies (INTA), University of Chile, Santiago, Chile.

When is the study starting and how long is it expected to run for?
July 2014 to October 2016.

Who is funding the study?
National Fund for Scientific & Technological Development (FONDECYT), (Chile)

Who is the main contact?
Prof. Fernando Pizarro
fpizarro@inta.uchile.cl

Trial website

Contact information

Type

Scientific

Primary contact

Prof Fernando Pizarro Aguirre

ORCID ID

Contact details

Institute of Nutrition and Food Technology (INTA)
University of Chile
El Líbano 5540
Macul
Santiago
13811
Chile
+56 (0)2 978 1522
fpizarro@inta.uchile.cl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Fondecyt Grant 1130090

Study information

Scientific title

Effect of combined iron, zinc, and calcium supplementation on iron, zinc, and calcium status in adolescents: a randomized controlled trial

Acronym

Study hypothesis

We hypothesize that combined iron, zinc, and calcium supplementation improves hematological indicators of iron, zinc, and calcium status in adolescents.

On 26/05/2015 the overall trial end date was changed from 30/10/2015 to 30/10/2016.

Ethics approval

The Ethics Committee of the Institute of Nutrition and Food Technology at the University of Chile, 27/06/2012, ref. resolution approval Nº 17

Study design

Randomized controlled double-blind clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Micronutrient deficiencies

Intervention

Patients will be randomly allocated to one of four groups:
1. Calcium supplemented group (control group)
2. Calcium plus Fe supplemented group
3. Calcium plus Zn supplemented group
4. Calcium, Fe and Zn supplemented group

The calcium (Ca) dose (650 mg) was defined based on 50% of the RDA for this age group. Iron and Zn doses will be established according with the current recommendation for these minerals. The supplementation period will last for 12 months.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Bone mineralization (as an outcome of Ca supplementation)
2. Iron nutrition status measured by:
2.1. Hemoglobin
2.2. Mean corpuscular volume
2.3. Zn protoporphyrin
2.4. Serum ferritin
2.5. Total iron binding capacity
2.6. Serum Iron
2.7. Hepcidin
2.8. Transferrin Receptor
2.9. Transferrin Saturation
2.10. Total body iron
3. Zinc nutrition status measured by circulating Zn levels

Secondary outcome measures

Not provided at time of registration

Overall trial start date

06/06/2014

Overall trial end date

30/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female
2. 16 - 17 years old
3. In good health
4. Sexual maturity rating of Tanner stage 5

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

One hundred and sixty subjects (n=160), 50% female

Participant exclusion criteria

1. Use of vitamin supplements containing iron, zinc, calcium, vitamin D during the last 6 months prior the beginning of the trial
2. Known intolerance/allergy to iron, zinc, and calcium supplements
3. Smoking and alcohol abuse or dependence
4. Morbidity (excepting anemia defined as hemoglobin < 120 g/L)
5. Participation in previous studies particularly involving the administration of micronutrient supplements
6. Pregnant or planning a pregnancy during the study period
7. Breastfeeding

Recruitment start date

01/05/2015

Recruitment end date

30/10/2016

Locations

Countries of recruitment

Chile

Trial participating centre

Institute of Nutrition and Food Technology (INTA)
Santiago
13811
Chile

Sponsor information

Organisation

University of Chile (Chile)

Sponsor details

Institute of Nutrition and Food Technology (INTA)
El Líbano 5540
Macul
Santiago
13811
Chile
+56 (0)2 29781400
fpizarro@inta.uchile.cl

Sponsor type

University/education

Website

http://www.uchile.cl/

Funders

Funder type

Government

Funder name

Fondo Nacional de Desarrollo Científico y Tecnológico

Alternative name(s)

National Fund for Scientific and Technological Development, FONDECYT

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Chile

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes