OBJECTIVE: To evaluate the effects of oral zinc supplementation on the serum zinc levels of pregnant women. DESIGN: Experimental (double blinded randomized controlled trial). PLACE AND DURATION OF STUDY: PIMS and KRL Hospital, Islamabad, and community in tehsil Kahuta from April 2003 to April 2004. PATIENTS AND METHODS: Pregnant women of 10 to 16 weeks gestation were invited to enter the study on their booking visit. A sample size of 125 in each group was calculated. After taking an informed consent, they were assigned to control or test group by simple random sampling technique. A detailed questionnaire was filled-up by trained staff and initial evaluation along with serum zinc samples was collected. The subjects were given either zinc sulphate powder, equivalent to 20 mg elemental zinc, or were given placebo treatment along with routine supplements. These patients were followed up throughout the pregnancy by health care providers and their compliance was monitored. At delivery, serum samples were again collected for zinc estimation. The data was entered on computer, cleaned and analyzed. Paired t-test was used for comparison of means. RESULTS: The data of 242 subjects was analyzed at the end of the study. The mean age of the study participants was 25.7 +/- 4.8 years (range 16 to 40). Both the groups were similar in other demographic variables as socioeconomic status, education, BMI, height and weight. One-third of the patients had serum zinc levels below 64 microg/dl at the start of the study. A 128 pairs of pre and post-serum zinc levels were analyzed in the two groups (64 pairs in each group) to compare the means. The zinc supplemented women showed a mean increase of 14.7 microg/dl (95% CI 5-23) (P = 0.002). On the other hand the non-supplemented group showed an actual decrease in the serum zinc level which, however, did not reach statistical significance (P = 0.47). CONCLUSION:Oral zinc supplementation of pregnant women with 20 mgelemental zinc was effective in raising the serum levels of zinc. It is suggested that supplementation trials with larger dose of zinc should be carried out.
RCT Entities:
OBJECTIVE: To evaluate the effects of oral zinc supplementation on the serum zinc levels of pregnant women. DESIGN: Experimental (double blinded randomized controlled trial). PLACE AND DURATION OF STUDY: PIMS and KRL Hospital, Islamabad, and community in tehsil Kahuta from April 2003 to April 2004. PATIENTS AND METHODS: Pregnant women of 10 to 16 weeks gestation were invited to enter the study on their booking visit. A sample size of 125 in each group was calculated. After taking an informed consent, they were assigned to control or test group by simple random sampling technique. A detailed questionnaire was filled-up by trained staff and initial evaluation along with serum zinc samples was collected. The subjects were given either zinc sulphate powder, equivalent to 20 mg elemental zinc, or were given placebo treatment along with routine supplements. These patients were followed up throughout the pregnancy by health care providers and their compliance was monitored. At delivery, serum samples were again collected for zinc estimation. The data was entered on computer, cleaned and analyzed. Paired t-test was used for comparison of means. RESULTS: The data of 242 subjects was analyzed at the end of the study. The mean age of the study participants was 25.7 +/- 4.8 years (range 16 to 40). Both the groups were similar in other demographic variables as socioeconomic status, education, BMI, height and weight. One-third of the patients had serum zinc levels below 64 microg/dl at the start of the study. A 128 pairs of pre and post-serum zinc levels were analyzed in the two groups (64 pairs in each group) to compare the means. The zinc supplemented women showed a mean increase of 14.7 microg/dl (95% CI 5-23) (P = 0.002). On the other hand the non-supplemented group showed an actual decrease in the serum zinc level which, however, did not reach statistical significance (P = 0.47). CONCLUSION: Oral zinc supplementation of pregnant women with 20 mg elemental zinc was effective in raising the serum levels of zinc. It is suggested that supplementation trials with larger dose of zinc should be carried out.