Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/01/2018
Date assigned
20/03/2018
Last edited
19/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ali Albelbeisi

ORCID ID

Contact details

Jalan SPS5/5
Off Persiaran Serdang Perdana
43300 Seri Kembangan
Selangor
Kuala Lumpur
0060
Malaysia
+60 (0)173186913
Alialbelbeisi@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Multiple micronutrient supplementation improves growth and hemoglobin of infants in Gaza Strip, Palestine: a randomized community trial

Acronym

Study hypothesis

Micronutrient supplements in powder form improves the nutritional status of Palestinian infants.

Ethics approval

Helsinki Committee for Ethical Approval, 15/09/2014, ref: PHRC/HC/27/14

Study design

Randomized community trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

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

Condition

Nutritional status including growth parameters, biomedical measures, and dietary intakes

Intervention

Upon screening, two hundred 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

Phase

Drug names

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 three 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 trial start date

04/09/2015

Overall trial end date

30/01/2017

Reason abandoned (if study stopped)

Eligibility

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 type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

200 (100 for each group)

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

Palestinian Territory

Trial participating centre

Two health care clinics of the UNRWA
Middle Area Governorate, Gaza Strip
00972
Palestinian Territory

Sponsor information

Organisation

University Putra Malaysia

Sponsor details

Faculty of Medicine and Health Sciences
43400 UPM Serdang
Selangor Daruh Ehsan
Kuala Lumpur
0060
Malaysia
+60 (0)389472606
chinys@upm.edu.my

Sponsor type

University/education

Website

http://www.medic.upm.edu.my/research-431

Funders

Funder type

University/education

Funder name

Universiti Putra Malaysia

Alternative name(s)

University Putra Malaysia, UPM

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Malaysia

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer reviewed journal.

IPD sharing statement
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).

Intention to publish date

23/06/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes