Effect of Cow's Milk Kefir on Short Chain Fatty Acid (SCFA), Haemoglobin, and Ferritin Levels of Anemic Adolescent Girls

NCT ID: NCT06957717

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-05-31

Brief Summary

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

Detailed Description

This protocol represents the only doctoral research dissertation proposal I will undertake as part of my dissertation, which does not exist.

Conditions

Iron Deficiency Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

intervention group

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.

Group Type: ACTIVE_COMPARATOR

cow's milk kefir

Intervention Type: COMBINATION_PRODUCT

group given cow's milk kefir and blood supplement tablets (TTD)

control group

Fresh cow's milk drink pasteurized at 72 °C, without fermentation, given 1 bottle/day of 132 ml for 2 months

Group Type: PLACEBO_COMPARATOR

pasteurized cow's milk

Intervention Type: COMBINATION_PRODUCT

group given pasteurized cow's milk and blood supplement tablets (TTD)

Interventions

cow's milk kefir

group given cow's milk kefir and blood supplement tablets (TTD)

Intervention Type: COMBINATION_PRODUCT

pasteurized cow's milk

group given pasteurized cow's milk and blood supplement tablets (TTD)

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

intervention group; control group

Eligibility Criteria

Inclusion Criteria

• Adolescent girls aged 15-18 years
• Have a mild and moderate degree of anemia (Hb 8-11.9 g/dl)
• Have a normal menstrual cycle and duration

Exclusion Criteria

• Suffering from thalassemia, hemosiderosis, blood cancer, and malaria, based on the doctor's diagnosis in the last 3 months
• Taking supplements other than TTD
• Taking antibiotics in the last 3 months
• Suffering from lactose intolerance through interviews

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lusyana Gloria Doloksaribu

OTHER

Sponsor Role: lead

Responsible Party

Lusyana Gloria Doloksaribu

doctoral students of the faculty of medicine, public health and nursing, Gadjah Mada University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Gadjah Mada University

Yogyakarta, Special Region of Yogyakarta, Indonesia

Countries

Indonesia

Central Contacts

Lusyana Gloria Doloksaribu

Role: CONTACT

lusyanagloriadoloksaribu@mail.ugm.ac.id

085360637111

Facility Contacts

Lusyana Gloria Doloksaribu, Doctoral student

Role: primary

lusyanagloriadoloksaribu@mail.ugm.ac.id

085360637111

Susetyowati, Promotor

Role: backup

susetyowati@ugm.ac.id

0818277781

Other Identifiers

GadjahMada

Identifier Type: -

Identifier Source: org_study_id