Effect of combined iron, zinc, and calcium supplementation on iron, zinc, and calcium status in adolescents
| ISRCTN | ISRCTN11852796 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11852796 |
| Secondary identifying numbers | Fondecyt Grant 1130090 |
- Submission date
- 06/06/2014
- Registration date
- 20/06/2014
- Last edited
- 29/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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 the diet can have negative effects on, for example, growth, psychomotor development (development of mental and physical skills), immunity and reproduction. 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 its 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 between 16-18 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 6 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
Contact information
Scientific
Institute of Nutrition and Food Technology (INTA)
University of Chile
El Líbano 5540
Macul
Santiago
13811
Chile
 ORCID ID |
0000-0001-6088-1119 |
|---|---|
| Phone | +56 (0)2 978 1522 |
| fpizarro@inta.uchile.cl |
Study information
| Study design | Randomized controlled double-blind clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effect of combined iron, zinc, and calcium supplementation on iron, zinc, and calcium status in adolescents: a randomized controlled trial |
| Study hypothesis | Combined iron, zinc, and calcium supplementation improves hematological indicators of iron, zinc, and calcium status in adolescents. |
| Ethics approval(s) | The Ethics Committee of the Institute of Nutrition and Food Technology at the University of Chile, 27/06/2012, ref. resolution approval Nº 17 |
| Condition | Micronutrient deficiencies |
| Intervention | Current interventions as of 18/01/2017: 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 (500 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 6 months. Previous interventions: 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 |
| Primary outcome measure | 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 study start date | 06/06/2014 |
| Overall study end date | 30/10/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 16 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | One hundred and sixty subjects (n=160), 50% female |
| Participant inclusion criteria | Current inclusion criteria as of 18/01/2017: 1. Male or female 2. 16 - 18 years old 3. In good health 4. Sexual maturity rating of Tanner stage 5 Previous inclusion criteria: 1. Male or female 2. 16 - 17 years old 3. In good health 4. Sexual maturity rating of Tanner stage 5 |
| 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
Study participating centre
13811
Chile
Sponsor information
University/education
Institute of Nutrition and Food Technology (INTA)
El Líbano 5540
Macul
Santiago
13811
Chile
| Phone | +56 (0)2 29781400 |
|---|---|
| fpizarro@inta.uchile.cl | |
| Website | http://www.uchile.cl/ |
"ROR" |
https://ror.org/04teye511 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Fund for Scientific and Technological Development, El Fondo Nacional de Desarrollo Científico y Tecnológico, FONDECYT
- Location
- Chile
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 29/01/2019 | 29/01/2019 | No | No |
Additional files
- ISRCTN11852796_BasicResults_29Jan19.pdf
- Uploaded 29/01/2019
Editorial Notes
29/01/2019: The following changes have been made to the trial record:
1. The intention to publish date has been changed from 31/03/2018 to 31/12/2019
2. The basic results summary has been uploaded as an additional file
15/01/2018: Intention to publish date was changed from 01/06/2017 to 31/03/2018.
26/05/2015: the overall trial end date was changed from 30/10/2015 to 30/10/2016.
