An interventional study of cow's milk kefir and pasteurized cow's milk in Iron Deficiency Anemia, sponsored by Lusyana Gloria Doloksaribu. Not yet recruiting at 1 site in Indonesia. Open to female participants aged 15 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Lusyana Gloria Doloksaribu · Not applicable, Interventional, and Treatment
Introduction: The prevalence of anemia among adolescent girls in Indonesia is still quite high. According to the Indonesian Health Survey (IHS) in 2023, it was 18% and is still a national problem. Long-term supplementation of blood supplement tablets (TTD) as an effort made by the government to prevent/overcome anemia has caused side effects, namely dysbiosis by pathogenic bacteria. Giving cow's milk kefir containing various probiotics can overcome the side effects of supplementation, and its metabolites accelerate iron absorption so that iron status in the blood increases and ultimately restores anemia in adolescent girls. Method: It's research is an experimental study, with a Randomized Controlled Trial (RCT) design, pre-posttest design, involving research subjects of adolescent girls (15-18 years) with mild and moderate anemia, at SMKN 1, 2, and 3 Kasihan, Bantul Regency, Yogyakarta as many as 80 students. Subjects were divided into 2 groups, namely group 1 (treatment group), which was given 120 ml of cow's milk kefir every day and TTD 1 grain/week, and group 2 (control group), which was given 120 ml of cow's milk every day and TTD 1 grain/week. The duration of administration was 2 months. The study outcomes were Short Chain Fatty Acid (SCFA) levels in feces by Gas Chromatography-Mass Spectrometry (GC-MS) method, hemoglobin by Hematology Analyser method, and serum ferritin by Ferritin ELISA measured at the beginning and end of the study. Statistical analysis included univariate, bivariate, and multivariate analysis. Clinical analysis was also conducted to estimate the effect size of the treatment
This protocol represents the only doctoral research dissertation proposal I will undertake as part of my dissertation, which does not exist.
660 studies on the registry are indexed under Anemia, Iron-Deficiency; 106 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 515 interventional studies indexed under Anemia, Iron-Deficiency.
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Exclusion Criteria:
Fresh cow's milk drink pasteurized at 72 °C, and fermented by kefir grain (5%) for 24 hours at 25 °C, then filtered to produce cow's milk kefir, and stored at 4 °C for 24 hours before drinking, given as 1 bottle/day of 120 ml + 10% liquid sugar for 2 months.
Combination Product: cow's milk kefir
Fresh cow's milk drink pasteurized at 72 °C, without fermentation, given 1 bottle/day of 132 ml for 2 months
Combination Product: pasteurized cow's milk
group given cow's milk kefir and blood supplement tablets (TTD)
Also known as: intervention group
group given pasteurized cow's milk and blood supplement tablets (TTD)
Also known as: control group
Short Chain Fatty Acid
SCFA (acetate, propionate, and butyrate) levels in fresh feces of adolescent girls, using the GC-MS (Gas Chromatography-Mass Spectrometry) Method, were measured before (0 months) and after the intervention (2 months), using a ratio scale. The examination procedure included collecting feces in the field according to the procedure at https://drive.google.com/drive/folders/1uXklwFuC-1rnQ1Anim86b7-9pqLSheIz. Fresh feces samples were collected immediately, by storing them in a cool box (to maintain the quality of feces so that it remains stable during storage and transportation, and avoid the maturation process that can affect the results of lab tests, so that the results of the lab analysis carried out can be accurate and valid), and then immediately taken to the laboratory to quantify each of the short chain fatty acids (SCFA) in the sample.
Time frame: 2 months after intervention
hemoglobin
Adolescent girls' hemoglobin values in the blood taken from the median cubital vein, using the hematology analyzer method (unit g/dl), were measured before (0 months) and after the intervention (2 months), using a ratio scale.
Time frame: 2 months after intervention
Ferritin
Ferritin content in the blood of adolescent girls taken from the median cubital vein, using the Ferritin ELISA method (unit µg/L), was measured before (0 months) and after the intervention (2 months), using a ratio scale
Time frame: 2 months after intervention
Nutrient intake
The amount of nutrients iron, folic acid, protein, vitamin C, zinc, energy and fat that enter the body of adolescent girls per day obtained from food and beverages, using the Food Record method carried out for 3 days, consisting of 2 times weekday and 1 time weekend, analyzed using the Nutrisurvey 2007 application, measured before (0 months) and after the intervention (2 months), using a ratio scale.
Time frame: 2 months after intervention
Nutritional status of adolescent girls (body mass index / age)
The Z-score or standard deviation (SD) value of adolescent girls after calculating the ratio of body weight in kilograms (kg) squared with height in meters (m) correlated with age, was analyzed using the WHO AnthroPlus application, measured before (0 months) and after the intervention (2 months), using a ratio scale. Weight values were obtained by weighing adolescent girls using digital scales with an accuracy of 0.1 kg. Height values were obtained by measuring the height of adolescent girls using a microtoise with an accuracy of 0.1 cm, and age was obtained by asking about the date/month/year of birth of adolescent girls. Using a questionnaire.
Time frame: 2 months after intervention
Menstrual cycle and duration of adolescent girls
The physiological process experienced by adolescent girls, namely periodic bleeding from the uterus accompanied by the release of the endometrial wall every month, was obtained through a questionnaire, using an ordinal scale, with the categories (1). Normal if the menstrual cycle ranges from 21-35 days, and the length of menstruation is 3-7 days, and (2). Abnormal if the menstrual cycle ranges \<21 days and \>35 days, and the duration of menstruation is \<3 days and \>7 days
Time frame: 2 months after intervention
Diarrhea
Complaints of watery or loose bowel movements that occur more than 3 times a day were obtained through a questionnaire, using an ordinal scale, with the categories (1). No diarrhea if the frequency of bowel movements ranged from 1-2 times/day, with a solid consistency, and (2). Diarrhea, the frequency of bowel movements ranging ≥3 times/day, watery, thin consistency
Time frame: 2 months after intervention
Plan to share: Yes — IPD data will be shared, but in the form of coding.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: IPD can be obtained after the dissertation is registered at the Universitas Gadjah Mada Library or the Faculty of Medicine, Public Health, and Nursing Library
Access criteria: Only investigator
Data sharing details ↗ · lib.ugm.ac.id
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Dec 2025, 7 months later.
Of 127 non-industry interventional studies with no phase under Anemia, Iron-Deficiency, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 27. This study's planned 7 months is below that.
Counting every sponsor, half of 139 studies reached it within 11 months; a quarter within 4 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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