CompletedNCT03112382SLC30A8Updated Aug 8, 2017

Effect of SLC30A8 rs13266634 Genetic Polymorphism on Zinc Supplementation and Glycemic Control in Egyptian Patients With Type 2 Diabetes Mellitus

A Phase 4 interventional study of zinc supplement plus vitamin A and E and vitamin A and E in Diabetes Mellitus, Type II, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-08.

Sponsored by Cairo University · Phase 4, Interventional, and Screening

Phase: Phase 4
Study type: Interventional
Enrollment: 80
Allocation: Randomized
Ages: 20 Years to 64 Years
Sex: All

Study summary

Study whether SLC30A8 rs13266634 polymorphism is associated with type 2 diabetes mellitus (T2DM) susceptibility in Egyptian patients and study effect of Zn supplementation on glycemic control in patients with type 2 diabetes

Conditions studied

Diabetes Mellitus, Type II

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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 80 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

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Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Established diagnosis of type 2 diabetes mellitus.
Age between 20 and 64 years.
BMI \< 40 kg/m2.
On fixed oral hypoglycemic dosage for at least 3 months.
Normal serum creatinine (0.5 to 1.3 mg/dL) with no clinical evidence suggestive kidney disease.
Normal liver function tests (ALT 7 to 55 U/L, and albumin ˃ 3.5 g/dL).

Exclusion criteria

Exclusion Criteria:

Those diagnosed of osteomalacia, chronic alcoholics. Patients with type 1 Diabetes Mellitus.
Those who were taking multivitamin containing zinc or magnesium or any sort of mineral supplements in the previous three months or hormone replacement therapy (estrogen, progesterone) or chelating therapy such as penicillamine, or anticonvulsant (phenytoin, valproate).
Those with a history of recent surgery or with concurrent acute illness including infectious disease, trauma, inflammatory bowel disease, malignancy, and active immunological diseases, using corticosteroids.
Pregnant or intend to be pregnant for t least 3 months or lactating women.
Those who were receiving insulin preparations as a part of diabetes management.

Study design

Phase: Phase 4
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 80 participants (estimated)

Study arms

Active comparator
zinc supplement plus vitamin A and E
patients will be receiving zinc supplement plus vitamin A and E for 3 months.
Drug: zinc supplement plus vitamin A and E
Active comparator
vitamin A and E
patients will be receiving equivalent dose of vitamin A and E only for 3 months
Drug: vitamin A and E
No intervention
no vitamins
patients will be observed for 3 months

Interventions

Drugzinc supplement plus vitamin A and E
Drugvitamin A and E

What researchers measure

Primary outcomes

SLC30A8 rs13266634 polymorphism
genetic screening of SLC30A8 : solute carrier family 30 member 8
Time frame: one year
serum zinc
Time frame: at base line

Secondary outcomes

change from baseline in fasting and 2hr post prandial blood glucose at three months
Time frame: at base line and after three months
change from baseline in HbA1c at three months
Time frame: base line and three months
change from baseline in lipid profile at three months
lipid profile: total cholesterol, triglyceride, HDL, LDL.
Time frame: base line and three months
change from baseline in fasting serum insulin at three months
Time frame: baseline and three months
change from baseline in ALT level at three months
Time frame: baseline and three months
serum Mg
Time frame: baseline
creatinine level
Time frame: baseline
serum Iron
Time frame: baseline
change from baseline in total serum Calcium at three months
Time frame: baseline and three months

Study locations

1 site

theoutpatient clinics, department of internal medicine, Cairo University teaching hospitals,
Cairo, Egypt

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03112382
Lead sponsor: Cairo University
Responsible party: Eman Said (Assisstant lecturer, Cairo University) — Principal investigator
First posted: Apr 13, 2017
Start date: Nov 2015
Primary completion: May 2017
Completion: May 2017
Last update: Aug 8, 2017

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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