Multiple micronutrient supplementation improves growth and hemoglobin of infants in Gaza Strip, Palestine
| ISRCTN | ISRCTN57594793 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57594793 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/01/2018
- Registration date
- 20/03/2018
- Last edited
- 07/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Growth faltering (slower than expected rate of growth) is a common form of undernutrition in developing countries. A lack of micronutrients including vitamin A, vitamin D, iron, and zinc has been associated with undernutrition in young children, particularly growth retardation. The aim of this study is to determine the impact of micronutrient powder supplementation on the nutritional status of infants in Gaza Strip, Palestine.
Who can participate?
Infants aged 6 months
What does the study involve?
The infants are randomly allocated into two groups to receive either the National Micronutrient Supplement or both a micronutrient powder and the National Micronutrient Supplement. Weight, length, circumference of head, waist and mid-upper arm, triceps and subscapular skinfolds (for body fat determination), and blood haemoglobin are measured. Information on the infants’ nutrient intakes is also obtained from their mothers.
What are the possible benefits and risks of participating?
The infants' nutritional status is expected to improve. No risks are expected from the blood samples or the supplements.
Where is the study run from?
Two healthcare clinics of the United Nations Relief and Works Agency (UNRWA) in the middle area governorate of Gaza Strip, Palestine
When is the study starting and how long is it expected to run for?
September 2015 to January 2017
Who is funding the study?
Universiti Putra Malaysia
Who is the main contact?
Ali Albelbeisi
Alialbelbeisi@gmail.com
Contact information
Scientific
Jalan SPS5/5, Off Persiaran Serdang Perdana
43300 Seri Kembangan, Selangor
Kuala Lumpur
0060
Malaysia
| Phone | +60 (0)173186913 |
|---|---|
| Alialbelbeisi@gmail.com |
Study information
| Study design | Randomized community trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Multiple micronutrient supplementation improves growth and hemoglobin of infants in Gaza Strip, Palestine: a randomized community trial |
| Study hypothesis | Micronutrient supplements in powder form improves the nutritional status of Palestinian infants. |
| Ethics approval(s) | Helsinki Committee for Ethical Approval, 15/09/2014, ref: PHRC/HC/27/14 |
| Condition | Nutritional status including growth parameters, biomedical measures, and dietary intakes |
| Intervention | Upon screening, 200 children were randomly selected (50% male and 50% female) using a table of random numbers. The random allocation procedures were employed to assign children to experimental and control groups. To avoid selection bias and reduce the chances of imbalance between groups, sealed opaque envelope method was used to assign children to groups. The infants were randomly assigned into two groups: 1. Control (National Micronutrient Supplement) 2. Experimental (micronutrient powder with National Micronutrient Supplement) The micronutrient powder contains 15 vitamins and minerals. The National Micronutrient Supplement consists of vitamin A, vitamin D and iron. Micronutrient powder (Mix meTM) was produced by DSM Nutritional Products Europe, Switzerland. The study protocol scheduled administration of micronutrient powder for 12 months as 3 sachets per week (every other day). Weight, length, circumferences of head, waist and mid-upper arm, triceps and subscapular skinfolds, and blood hemoglobin were measured. Information on children’s nutrient intakes was also obtained from the mothers. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Anthropometric measures, including body weight, length, circumferences of the head, waist, and mid-upper arm, and triceps and subscapular skinfold thickness, measured at baseline and throughout the study period (every 3 to 6 months). Z scores of these measures calculated by the WHO Anthro software, version 3.2.2, waist circumference z scores calculated based on the reference data obtained from Turkish under-six years children 2. Hemoglobin concentration: finger or heel prick blood obtained by the lab technician of the UNRWA clinic and analyzed for hemoglobin level using spectrophotometer (colorimeter) at baseline, end of the intervention, and 3 months after the end of intervention period |
| Secondary outcome measures | Calorie and nutrient intakes, including energy, carbohydrate, fat, protein, iron, vitamin A, and vitamin D, assessed using one day of 24-hour diet recall at baseline, 6 months of intervention, and at the end of the intervention period |
| Overall study start date | 04/09/2015 |
| Overall study end date | 30/01/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 5 Months |
| Sex | Both |
| Target number of participants | 200 (100 for each group) |
| Total final enrolment | 200 |
| Participant inclusion criteria | 1. Male or female infants 2. Aged 5 months + 2 weeks 3. Have normal z scores (>-2 to <+2 SD) of Wt/age, Lt/age and Hc/age 4. Have birth weight ≥ 2.5 to ≤ 4 kg 5. Have appropriate for gestational age (between the 10th and 90th percentile) 6. Have blood level of hemoglobin ≥ 11 gram per deciliter 7. Breastfed for at least 4 months 8. Visited the UNRWA clinics for vaccination and/or routine child's growth follow up |
| Participant exclusion criteria | 1. Preterm infants (˂37 weeks) 2. Infants who have a history of chronic diseases (e.g. failure to thrive and metabolic or endocrine disorders) 3. Infants of diabetic mothers 4. Have a history of complications during delivery (aspiration, trauma) 5. Have a history of congenital and/or acquired neurological diagnosis (e.g., Down syndrome or cerebral palsy) |
| Recruitment start date | 01/10/2015 |
| Recruitment end date | 01/01/2017 |
Locations
Countries of recruitment
- Palestine, State of
Study participating centre
00972
Palestine, State of
Sponsor information
University/education
Faculty of Medicine and Health Sciences
43400 UPM Serdang, Selangor Daruh Ehsan
Kuala Lumpur
0060
Malaysia
| Phone | +60 (0)389472606 |
|---|---|
| chinys@upm.edu.my | |
| Website | http://www.medic.upm.edu.my/research-431 |
"ROR" |
https://ror.org/02e91jd64 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University Putra Malaysia, UPM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 23/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Ali H.A. Albelbeisi (Alialbelbeisi@gmail.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/12/2020 | 07/12/2020 | Yes | No |
Editorial Notes
07/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
