Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201303000453309 Date of Approval: 11/11/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Does zinc supplementation improve pregnancy outcome of women in Alexandria, Egypt?
Official scientific title Effect of zinc supplementation on pregnancy outcome among women in Alexandria Egypt : A randomized controlled trial .
Brief summary describing the background and objectives of the trial ¿ The study population comprised 1055 healthy pregnant women aged 20-45 years who were assessed for eligibility. The inclusion criteria for recruitment of participants were: low serum zinc level below the estimated median for the gestational age, <16-week period of gestation and BMI between 18-26 kg/m2. Accordingly, only 675 were suitable for enrollment to the study. A three-arm design was used in which participants were randomly assigned to one of 3 parallel groups in 1:1:1 ratio. Group 1 received placebo, group 2 received zinc and group 3 received zinc plus multivitamins. Supplements were given from 16 weeks gestation till delivery. These 675 cases were followed up till delivery. Monitoring, follow up and assessment of pregnancy outcomes for pregnant women were done on a monthly basis during the antenatal care visits and for newborn babies for one week after delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) none
Disease(s) or condition(s) being studied Pregnancy and Childbirth,Pregnancy outcome .
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 03/02/2007
Actual trial start date 12/02/2007
Anticipated date of last follow up 09/02/2009
Actual Last follow-up date 14/05/2009
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 675
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group zinc capsules 30 mg zinc sulphate from 16 weeks gestation till delivery capsules 225
Experimental Group zinc plus multivitamines Daily 16 weeks gestation till delivery capsules 227
Control Group Placebo group daily 16 weeks gestation till delivery capsules 223
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women attending the health centers for antenatal care with the following characteristics were eligible for enrollment to the study: 1. Age range between 20-45 years. 2. Gestational age < 16 weeks assessed by recall of last menstrual period (LMP) and confirmed by Ultrasonography. 3. BMI between 18-26 kg/m2. 4. Normal course of pregnancy. 5. Women with predetermined risk of zinc deficiency at initial assessment. The risk was determined according to the serum zinc concentration. Women with a serum zinc level below the estimated median for gestational age at the time of enrollment were considered eligible for intervention. The cut off point for low serum zinc level was estimated according to a recent study. - Women identified through interviews to be on any other form of zinc supplements at any dosage. - Women with an established risk of having reduced or excessive birth weight of infants (e.g., diabetes, hypertension, renal and heart disease). - Old primigravidae. - Cases that developed complications or twin pregnancy during the follow up period. 20 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes Ministry of Health and Population, Central Administration for Research and Health Development.
Ethics Committee Address
Street address City Postal code Country
: 3 Magles Elshaab St; Cairo Cairo . 115111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- Birth weight. ¿ Birth weight measured within one week of birth
Primary Outcome 2- Delivery data: First week from delivery during birth registration .
Secondary Outcome Serum zinc after supplementation . the second plasma zinc concentration measurement at 28Th ¿ 32th weeks gestation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Somouha MCH Center 6 Zaki Ragab St; Alexandria . 21561(El-Hadara Bah Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The researcher Mostafa Kamel ,St;18,building no.76 ;apart 73 . Alexandria . 21612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor High Institute of Public Health . 165 Horreya St; Alexandria . 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
High Institute of Public Health . 165 Horreya St; Alexandria . 21561 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Noha Ebrahim Naeem Naeem dr_nohanaeim@yahoo.com 01224026459 76 Mostafa Kamell Military Buildings .
City Postal code Country Position/Affiliation
Alexandria . 21612 Egypt Researcher
Role Name Email Phone Street address
Public Enquiries Nawal El-Sayed nawalelsayed@hotmail.com 01222291004 El-Khartoum Street ,Azarita .
City Postal code Country Position/Affiliation
Alexandria 21612 Egypt Prof; Dept;Nutrition.High Institute of Puplic health
Role Name Email Phone Street address
Scientific Enquiries Samia Nossier samia_nossier@yahoo.com 0107693926 Smouha, University buildings, Block 2, Flat72
City Postal code Country Position/Affiliation
Alexandria . 21554 Egypt Dept. of Maternal and Child Health, High Institute of Public Health
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information